Study record managers: refer to the Data Element Definitions if submitting registration or results information.
研究记录管理员：如果提交注册或结果信息，请参阅数据元素定义。
A type of eligibility criteria that indicates whether people who do not have the condition/disease being studied can participate in that clinical study.
An arm type in which a group of participants receives an intervention/treatment considered to be effective (or active) by health care providers.
An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of time after the study has ended. This change may or may not be caused by the intervention/treatment being studied.
A type of eligibility criteria that indicates the age a person must be to participate in a clinical study. This may be indicated by a specific age or the following age groups:
The age groups are:
Child (birth-17)
Adult (18-64)
Older Adult (65+)
A measure of all deaths, due to any cause, that occur during a clinical study.
A method used to assign participants to an arm of a clinical study. The types of allocation are randomized allocation and nonrandomized.
A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
A general description of the clinical trial arm. It identifies the role of the intervention that participants receive. Types of arms include experimental arm, active comparator arm, placebo comparator arm, sham comparator arm, and no intervention arm.
Data collected at the beginning of a clinical study for all participants and for each arm or comparison group. These data include demographics, such as age, sex/gender, race and ethnicity, and study-specific measures (for example, systolic blood pressure, prior antidepressant treatment).
Indicates that the study sponsor or investigator recalled a submission of study results before quality control (QC) review took place. If the submission was canceled on or after May 8, 2018, the date is shown. After submission of study results, a study record cannot be modified until QC review is completed, unless the submission is canceled.
Information required by the Food and Drug Administration Amendments Act of 2007. In general, this is a description of any agreement between the sponsor of a clinical study and the principal investigator (PI) that does not allow the PI to discuss the results of the study or publish the study results in a scientific or academic journal after the study is completed.
A sponsor or investigator may submit a certification to delay submission of results information if they are applying for FDA approval of a new drug or device, or new use of an already approved drug or device. A sponsor or investigator who submits a certification can delay results submission up to 2 years after the certification/extension first submitted date, unless certain events occur sooner. See Delay Results Type in the Results Data Element definitions for more information about this certification.
The date on which information about a certification to delay submission of results or an extension request was first available on ClinicalTrials.gov. ClinicalTrials.gov does not indicate whether the submission was a certification or extension request. There is typically a delay between the date the study sponsor or investigator submitted the certification or extension request and the first posted date.
The date on which the study sponsor or investigator first submitted a certification or an extension request to delay submission of results. A sponsor or investigator who submits a certification can delay results submission up to 2 years after this date, unless certain events occur sooner. There is typically a delay between the date the certification or extension request was submitted and the date the information is first available on ClinicalTrials.gov (certification/extension first posted).
The date on which the study sponsor or investigator first submitted a certification or an extension request that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a certification or extension request one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria. Meeting QC criteria for an extension request does not mean that the National Institutes of Health (NIH) has determined that the request demonstrates good cause. The process for review and granting of extension requests by the NIH is being developed.
In the search feature, the City field is used to find clinical studies with locations in a specific city. The Distance field is used to find studies with locations within the specified distance from a city in number of miles. For example, if you choose Illinois as the state, identifying "Chicago" as the city and "100 miles" as the distance will find all studies listing a location within 100 miles of Chicago.
A research study involving human volunteers (also called participants) that is intended to add to medical knowledge. There are two types of clinical studies: interventional studies (also called clinical trials) and observational studies.
Another name for an interventional study.
The unique identification code given to each clinical study upon registration at ClinicalTrials.gov. The format is "NCT" followed by an 8-digit number (for example, NCT00000419).
An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
In the search feature, the Country field is used to find clinical studies with locations in a specific country. For example, if you choose the United States, you can then narrow your search by selecting a state and identifying a city and distance.
A type of intervention model describing a clinical trial in which groups of participants receive two or more interventions in a specific order. For example, two-by-two cross-over assignment involves two groups of participants. One group receives drug A during the initial phase of the trial, followed by drug B during a later phase. The other group receives drug B during the initial phase, followed by drug A. So during the trial, participants "cross over" to the other drug. All participants receive drug A and drug B at some point during the trial but in a different order, depending on the group to which they are assigned.
A group of independent scientists who monitor the safety and scientific integrity of a clinical trial. The DMC can recommend to the sponsor that the trial be stopped if it is not effective, is harming participants, or is unlikely to serve its scientific purpose. Members are chosen based on the scientific skills and knowledge needed to monitor the particular trial. Also called a data safety and monitoring board, or DSMB.
A phase of research used to describe exploratory trials conducted before traditional phase 1 trials to investigate how or whether a drug affects the body. They involve very limited human exposure to the drug and have no therapeutic or diagnostic goals (for example, screening studies, microdose studies).
The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.
The number of participants in a clinical study. The "estimated" enrollment is the target number of participants that the researchers need for the study.
A type of eligibility criteria. These are reasons that a person is not allowed to participate in a clinical study.
A way for patients with serious diseases or conditions who cannot participate in a clinical trial to gain access to a medical product that has not been approved by the U.S. Food and Drug Administration (FDA). Also called compassionate use. There are different expanded access types.
Available:Expanded access is currently available for this investigational treatment, and patients who are not participants in the clinical study may be able to gain access to the drug, biologic, or medical device being studied.
No longer available:Expanded access was available for this intervention previously but is not currently available and will not be available in the future.
Temporarily not available:Expanded access is not currently available for this intervention but is expected to be available in the future.
Approved for marketing: The intervention has been approved by the U.S. Food and Drug Administration for use by the public.
Describes the category of expanded access under U.S. Food and Drug Administration (FDA) regulations. There are three types of expanded access:
Individual Patients: Allows a single patient, with a serious disease or condition who cannot participate in a clinical trial, access to a drug or biological product that has not been approved by the FDA. This category also includes access in an emergency situation.
Intermediate-size Population: Allows more than one patient (but generally fewer patients than through a Treatment IND/Protocol) access to a drug or biological product that has not been approved by the FDA. This type of expanded access is used when multiple patients with the same disease or condition seek access to a specific drug or biological product that has not been approved by the FDA.
Treatment IND/Protocol: Allows a large, widespread population access to a drug or biological product that has not been approved by the FDA. This type of expanded access can only be provided if the product is already being developed for marketing for the same use as the expanded access use.
An arm type in which a group of participants receives the intervention/treatment that is the focus of the clinical trial.
In certain circumstances, a sponsor or investigator may request an extension to delay the standard results submission deadline (generally one year after the primary completion date). The request for an extension must demonstrate good cause (for example, the need to preserve the scientific integrity of an ongoing masked trial). All requests must be reviewed and granted by the National Institutes of Health. This process for review and granting of extension requests is being developed. See Delay Results Type in the Results Data Element definitions for more information.
A type of intervention model describing a clinical trial in which groups of participants receive one of several combinations of interventions. For example, two-by-two factorial assignment involves four groups of participants. Each group receives one of the following pairs of interventions: (1) drug A and drug B, (2) drug A and a placebo, (3) a placebo and drug B, or (4) a placebo and a placebo. So during the trial, all possible combinations of the two drugs (A and B) and the placebos are given to different groups of participants.
A FDAAA 801 Violation is shown on a study record when the U.S. Food and Drug Administration (FDA) has issued a Notice of Noncompliance to the responsible party of an applicable clinical trial. A Notice of Noncompliance indicates that the FDA has determined the responsible party was not in compliance with the registration or results reporting requirements for the clinical trial under the Food and Drug Administration Amendments Act of 2007, Section 801 (FDAAA 801).
The National Library of Medicine (NLM) is required by FDAAA 801 to add information to a study record about any FDAAA 801 Violation. This information is provided by the FDA. There are three categories of information that may be included:
Violation: Shown when the FDA issues a Notice of Noncompliance and posts the Notice of Noncompliance on its designated webpage. There are three types of violations:
Failure to submit required clinical trial information
Submission of false or misleading clinical trial information
Failure to submit primary and secondary outcomes
Correction: Shown when the FDA confirms that the responsible party has updated the study record to correct the violation and posts the correction notice on its designated webpage. Because of the time for FDA review and processing, there may be a delay between the date when the study record was updated and the addition of correction information to the FDAAA 801 Violation information.
Penalty: Shown when the FDA imposes a penalty for the violation and posts the penalty notice on its designated webpage.
The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
U.S. Public Law 110-85, which was enacted on September 27, 2007. Section 801 of FDAAA amends Section 402 of the U.S. Public Health Service Act to expand ClinicalTrials.gov and create a clinical study results database. For more information on FDAAA 801, see the Clinical Trial Reporting Requirements page on this site.
Describes the organization that provides funding or support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting. Organizations listed as sponsors and collaborators for a study are considered the funders of the study. ClinicalTrials.gov refers to four types of funders:
U.S. National Institutes of Health
Other U.S. Federal agencies (for example, Food and Drug Administration, Centers for Disease Control and Prevention, or U.S. Department of Veterans Affairs)
Industry (for example: pharmaceutical and device companies)
All others (including individuals, universities, and community-based organizations)
A type of eligibility criteria that indicates whether eligibility to participate in a clinical study is based on a person's self-representation of gender identity. Gender identity refers to a person's own sense of gender, which may or may not be the same as their biological sex.
A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
A group of people who review, approve, and monitor the clinical study's protocol. Their role is to protect the rights and welfare of people participating in a study (referred to as human research subjects), such as reviewing the informed consent form. The group typically includes people with varying backgrounds, including a community member, to make sure that research activities conducted by an organization are completely and adequately reviewed. Also called an institutional review board, or IRB, or an ethics committee.
A type of eligibility criteria. These are the reasons that a person is allowed to participate in a clinical study.
A process used by researchers to communicate to potential and enrolled participants the risks and potential benefits of participating in a clinical study.
The document used in the informed consent or process.
The general design of the strategy for assigning interventions to participants in a clinical study. Types of intervention models include: single group assignment, parallel assignment, cross-over assignment, and factorial assignment.
A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
A type of clinical study in which participants are assigned to groups that receive one or more intervention/treatment (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. The assignments are determined by the study's protocol. Participants may receive diagnostic, therapeutic, or other types of interventions.
A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
The most recent date on which the study sponsor or investigator submitted changes to a study record to ClinicalTrials.gov. There is typically a delay of a few days between the last update submitted date and when the date changes are posted on ClinicalTrials.gov (the last update posted date).
The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
Countries in which research facilities for a study are located. A country is listed only once, even if there is more than one facility in the country. The list includes all countries as of the last update submitted date; any country for which all facilities were removed from the study record are listed under removed location countries.
In the search feature, the Location terms field is used to narrow a search by location-related terms other than Country, State, and City or distance. For example, you may enter a specific facility name (such as National Institutes of Health Clinical Center) or a part of a facility name (such as Veteran for studies listing Veterans Hospital or Veteran Affairs in the facility name). Note: Not all study records include this level of detail about locations.
A clinical trial design strategy in which one or more parties involved in the trial, such as the investigator or participants, do not know which participants have been assigned which interventions. Types of masking include: open label, single blind masking, and double-blind masking.
A unique identification code given to each clinical study record registered on ClinicalTrials.gov. The format is "NCT" followed by an 8-digit number (for example, NCT00000419). Also called the ClinicalTrials.gov identifier.
An arm type in which a group of participants does not receive any intervention/treatment during the clinical trial.
A type of clinical study in which participants are identified as belonging to study groups and are assessed for biomedical or health outcomes. Participants may receive diagnostic, therapeutic, or other types of interventions, but the investigator does not assign participants to a specific interventions/treatment.
A patient registry is a type of observational study.
The general design of the strategy for identifying and following up with participants during an observational study. Types of observational study models include cohort, case-control, case-only, case-cross-over, ecologic or community studies, family-based, and other.
An adverse event that is not a serious adverse event, meaning that it does not result in death, is not life-threatening, does not require inpatient hospitalization or extend a current hospital stay, does not result in an ongoing or significant incapacity or interfere substantially with normal life functions, and does not cause a congenital anomaly or birth defect; it also does not put the participant in danger and does not require medical or surgical intervention to prevent one of the results listed above.
Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
In the search feature, the Other terms field is used to narrow a search. For example, you may enter the name of a drug or the NCT number of a clinical study to limit the search to study records that contain these words.
For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
A type of intervention model describing a clinical trial in which two or more groups of participants receive different interventions. For example, a two-arm parallel assignment involves two groups of participants. One group receives drug A, and the other group receives drug B. So during the trial, participants in one group receive drug A "in parallel" to participants in the other group, who receive drug B.
A summary of the progress of participants through each stage of a clinical study, by study arm or group/cohort. This includes the number of participants who started, completed, and dropped out of the study.
A type of observational study that collects information about patients' medical conditions and/or treatments to better understand how a condition or treatment affects patients in the real world.
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
A phase of research to describe clinical trials that focus on the safety of a drug. They are usually conducted with healthy volunteers, and the goal is to determine the drug's most frequent and serious adverse events and, often, how the drug is broken down and excreted by the body. These trials usually involve a small number of participants.
A phase of research to describe clinical trials that gather preliminary data on whether a drug works in people who have a certain condition/disease (that is, the drug's effectiveness). For example, participants receiving the drug may be compared to similar participants receiving a different treatment, usually an inactive substance (called a placebo) or a different drug. Safety continues to be evaluated, and short-term adverse events are studied.
A phase of research to describe clinical trials that gather more information about a drug's safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. These studies typically involve more participants.
A phase of research to describe clinical trials occurring after FDA has approved a drug for marketing. They include postmarket requirement and commitment studies that are required of or agreed to by the study sponsor. These trials gather additional information about a drug's safety, efficacy, or optimal use.
Describes trials without FDA-defined phases, including trials of devices or behavioral interventions.
An inactive substance or treatment that looks the same as, and is given in the same way as, an active drug or intervention/treatment being studied.
An arm type in which a group of participants receives a placebo during a clinical trial.
The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "estimated" primary completion date is the date that the researchers think will be the primary completion date for the study.
In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
The main reason for the clinical trial. The types of primary purpose are: treatment, prevention, diagnostic, supportive care, screening, health services research, basic science, and other.
The person who is responsible for the scientific and technical direction of the entire clinical study.
The written description of a clinical study. It includes the study's objectives, design, and methods. It may also include relevant scientific background and statistical information.
National Library of Medicine (NLM) staff perform a limited review of submitted study records for apparent errors, deficiencies, or inconsistencies. NLM staff identify potential major and advisory issues and provide comments directly to the study sponsor or investigator. Major issues identified in QC review must be addressed or corrected (see First submitted that met QC criteria and Results first submitted that met QC criteria). Advisory issues are suggestions to help improve the clarity of the record. NLM staff do not verify the scientific validity or relevance of the submitted information. The study sponsor or investigator is responsible for ensuring that the studies follow all applicable laws and regulations.
A type of allocation strategy in which participants are assigned to the arms of a clinical trial by chance.
Not yet recruiting: The study has not started recruiting participants.
Recruiting: The study is currently recruiting participants.
Enrolling by invitation: The study is selecting its participants from a population, or group of people, decided on by the researchers in advance. These studies are not open to everyone who meets the eligibility criteria but only to people in that particular population, who are specifically invited to participate.
Active, not recruiting: The study is ongoing, and participants are receiving an intervention or being examined, but potential participants are not currently being recruited or enrolled.
Suspended: The study has stopped early but may start again.
Terminated: The study has stopped early and will not start again. Participants are no longer being examined or treated.
Completed: The study has ended normally, and participants are no longer being examined or treated (that is, the last participant's last visit has occurred).
Withdrawn: The study stopped early, before enrolling its first participant.
Unknown: A study on ClinicalTrials.gov whose last known status was recruiting; not yet recruiting; or active, not recruiting but that has passed its completion date, and the status has not been last verified within the past 2 years.
The process of submitting and updating summary information about a clinical study and its protocol, from its beginning to end, to a structured, public Web-based study registry that is accessible to the public, such as ClinicalTrials.gov.
Countries that appeared under listed location countries but were removed from the study record by the sponsor or investigator.
A grouping of participants in a clinical study that is used for summarizing the data collected during the study. This grouping may be the same as or different from a study arm or group.
The person responsible for submitting information about a clinical study to ClinicalTrials.gov and updating that information. Usually the study sponsor or investigator.
A structured online system, such as the ClinicalTrials.gov results database, that provides the public with access to registration and summary results information for completed or terminated clinical studies. A study with results available on ClinicalTrials.gov is described as having the results "posted."
Note: The ClinicalTrials.gov results database became available in September 2008. Older studies are unlikely to have results available in the database.
Indicates that the sponsor or investigator submitted a certification or extension request.
The date on which summary results information was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay between the date the study sponsor or investigator first submits summary results information (the results first submitted date) and the results first posted date. Some results information may be available at an earlier date if Results First Posted with QC Comments.
The date on which summary results information was first available on ClinicalTrials.gov with quality control review comments from the National Library of Medicine (NLM) identifying major issues that must be addressed by the sponsor or investigator. As of January 1, 2020, initial results submissions for applicable clinical trials (ACTs) that do not meet quality control review criteria will be publicly posted on ClinicalTrials.gov with brief standardized major comments. Accordingly, the Results First Posted with QC Comments date may be earlier than the Results First Posted date for an ACT with summary results information that is not consistent with NLM quality control review criteria.
The date on which the study sponsor or investigator first submits a study record with summary results information. There is typically a delay between the results first submitted date and when summary results information becomes available on ClinicalTrials.gov (the results first posted date).
The date on which the study sponsor or investigator first submits a study record with summary results information that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit results information one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
The date on which the National Library of Medicine provided quality control (QC) review comments to the study sponsor or investigator. The sponsor or investigator must address major issues identified in the review comments. If there is a date listed for results returned after quality control review, but there is not a subsequent date listed for results submitted to ClinicalTrials.gov, this means that the submission is pending changes by the sponsor or investigator.
Indicates that the study sponsor or investigator has submitted summary results information for a clinical study to ClinicalTrials.gov but the quality control (QC) review process has not concluded.
The results submitted date indicates when the study sponsor or investigator first submitted summary results information or submitted changes to summary results information. Submissions with changes are typically in response to QC review comments from the National Library of Medicine (NLM). If there is a date listed for results submitted to ClinicalTrials.gov, but there is not a subsequent date listed for results returned after quality control review, this means that the submission is pending review by NLM.
In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
An adverse event that results in death, is life-threatening, requires inpatient hospitalization or extends a current hospital stay, results in an ongoing or significant incapacity or interferes substantially with normal life functions, or causes a congenital anomaly or birth defect. Medical events that do not result in death, are not life-threatening, or do not require hospitalization may be considered serious adverse events if they put the participant in danger or require medical or surgical intervention to prevent one of the results listed above.
A type of eligibility criteria that indicates the sex of people who may participate in a clinical study (all, female, male). Sex is a person's classification as female or male based on biological distinctions. Sex is distinct from gender-based eligibility.
An arm type in which a group of participants receives a procedure or device that appears to be the same as the actual procedure or device being studied but does not contain active processes or components.
A type of intervention model describing a clinical trial in which all participants receive the same intervention/treatment.
The Sort studies by option is used to change the order of studies listed on the Search Results page. You can sort by Relevance or Newest First:
Relevance: Studies that best match your search terms appear higher in the search results list. This is the default display for all searches.
Newest First: Studies with the most recent First posted dates appear higher in the search results list.
The organization or person who initiates the study and who has authority and control over the study.
In the search feature, the State field is used to find clinical studies with locations in a specific state within the United States. If you choose United States in the Country field, you can search for studies with locations in a specific state.
The written description of the statistical considerations and methods for analyzing the data collected in the clinical study.
Indicates the current recruitment status or the expanded access status.
The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "estimated" study completion date is the date that the researchers think will be the study completion date.
The investigative methods and strategies used in the clinical study.
Refers to the type of documents that the study sponsor or principal investigator may add to their study record. These include a study protocol, statistical analysis plan, and informed consent form.
Identifiers that are assigned to a clinical study by the study's sponsor, funders, or others. They include unique identifiers from other trial study registries and National Institutes of Health grant numbers. Note: ClinicalTrials.gov assigns a unique identification code to each clinical study registered on ClinicalTrials.gov. Also called the NCT number, the format is "NCT" followed by an 8-digit number (for example, NCT00000419).
An entry on ClinicalTrials.gov that contains a summary of a clinical study's protocol information, including the recruitment status; eligibility criteria; contact information; and, in some cases, summary results. Each study record is assigned a ClinicalTrials.gov identifier, or NCT number.
A structured online system, such as ClinicalTrials.gov, that provides the public with access to summary information about ongoing and completed clinical studies.
A study record that includes the summary results posted in the ClinicalTrials.gov results database. Summary results information includes participant flow, baseline characteristics, outcome measures, and adverse events (including serious adverse events).
The actual date on which the first participant was enrolled in a clinical study. The "estimated" study start date is the date that the researchers think will be the study start date.
Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
The date on which the study sponsor or investigator submitted a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria.
The official title of a protocol used to identify a clinical study or a short title written in language intended for the lay public.
The acronym or initials used to identify a clinical study (not all studies have one). For example, the title acronym for the Women's Health Initiative is "WHI."
A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
An agency within the U.S. Department of Health and Human Services. AHRQ's mission is to produce evidence to make health care safer, higher quality, more accessible, equitable, and affordable, and to work within the U.S. Department of Health and Human Services and with other partners to make sure that the evidence is understood and used.
An agency within the U.S. Department of Health and Human Services. The FDA is responsible for protecting the public health by making sure that human and veterinary drugs, vaccines and other biological products, medical devices, the Nation's food supply, cosmetics, dietary supplements, and products that give off radiation are safe, effective, and secure.
A type of recruitment status. It identifies a study on ClinicalTrials.gov whose last known status was recruiting; not yet recruiting; or active, not recruiting but that has passed its completion date, and the status has not been verified within the past 2 years. Studies with an unknown status are considered closed studies.
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ClinicalTrials.gov is a website and online database of clinical research studies and information about their results. The National Library of Medicine (NLM) maintains the website. The study sponsor or investigator submits information about their study to ClinicalTrials.gov and is responsible for the safety, science, and accuracy of any study they list.
Before joining a study, talk to your health care professional about possible risks and benefits. To learn more about taking part in studies, read Learn About Studies(https://www.clinicaltrials.gov/study-basics/learn-about-studies).
Not yet recruiting 尚未招聘
Evaluation of Recombinant Norovirus Hexavalent Vaccine in Healthy Subjects 重组诺如病毒六价疫苗在健康受试者中的评价
ClinicalTrials.gov ID NCT05805618
Sponsor Syneos Health 赞助商 Syneos Health
Information provided by Syneos Health (Responsible Party) 信息由 Syneos Health（责任方）提供
To evaluate the safety and immunogenicity of different dose levels of the Recombinant Norovirus Hexavalent Vaccine in healthy subjects aged 18-59 years given three doses of the vaccine at 28-day intervals. 评估不同剂量水平的重组诺如病毒六价疫苗在 18-59 岁健康受试者中以 28 天的间隔接种三剂疫苗的安全性和免疫原性。
Detailed Description 详细说明
It is planned to enroll healthy subjects and adopt a 3-dose vaccination schedule (day 0 to day 56) of intramuscular injections of study vaccines in the deltoid muscle of the upper arm of subjects on day 0, day 28 and day 56, respectively.
The subjects will sequentially enter into the low and high dose groups by stages, with approximately 30 subjects in each group (test group:control group = 2:1) and approximately up to 60 subjects in total.
At least half of the subjects are Chinese in the two cohorts respectively 计划招募健康受试者，并采用 3 剂疫苗接种计划（第 0 天至第 56 天），分别在第 0 天、第 28 天和第 56 天在受试者上臂三角肌肌内注射研究疫苗。受试者将按阶段依次进入低剂量组和高剂量组，每组大约 30 名受试者（测试组：对照组 = 2：1），总共大约 60 名受试者。在这两个队列中，至少有一半的受试者分别是中国人
A Single-center, Randomized, Double-blind, Placebo-controlled Phase I Clinical Study to Evaluate the Safety and Immunogenicity of Recombinant Norovirus Hexavalent Vaccine in Healthy Subjects Aged 18-59 Years 一项单中心、随机、双盲、安慰剂对照的 I 期临床研究，以评估重组诺如病毒六价疫苗在 18-59 岁健康受试者中的安全性和免疫原性
This section provides the contact details for those conducting the study, and information on where this study is being conducted. 本节提供进行研究的人员的联系方式，以及有关该研究进行地点的信息。
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments. 研究人员寻找符合特定描述（称为资格标准）的人。这些标准的一些示例是一个人的一般健康状况或先前的治疗。
Subjects with a body mass index ( 18 kg/m2 and 35 kg/m2; 体重指数（18 kg/m2 和 35 kg/m2;
Capable and willing to give informed consent prior to any study-specific activities/procedures; 能够并愿意在任何特定于研究的活动/程序之前给予知情同意;
Subjects who are able to comply with the requirements of the clinical study protocol to complete the study; 能够遵守临床研究方案要求完成研究的受试者;
Subjects who haven't been vaccinated or haven't plan to be vaccinated with other vaccines (including live attenuated vaccines, non-live vaccines, and novel coronavirus vaccines) within 14 days before the first dose of study vaccines; 研究疫苗首次给药前 14 天内未接种或未计划接种其他疫苗（包括减毒活疫苗、非活疫苗和新型冠状病毒疫苗）的受试者;
Subjects who are clinically determined to be healthy by the investigator after being inquired about their medical history and relevant physical examinations; 经询问病史和相关体格检查后，研究者临床确定为健康的受试者;
Female subjects who are not breastfeeding; all subjects who have no childbearing plan or sperm/egg donation plan from ICF signing to 6 months after the completion of the vaccination series and agree to take effective contraceptive measures (See the appendix 3) from 4 weeks prior to the first dose to 6 months after the completion of the vaccination series. 未进行母乳喂养的女性受试者;所有从 ICF 签署到疫苗接种系列完成后 6 个月没有生育计划或精子/卵子捐献计划并同意在第一次接种前 4 周至疫苗接种后 6 个月内采取有效避孕措施（见附录 3）的受试者。
Exclusion criteria for the first vaccination dose 第一剂疫苗接种的排除标准
Subjects with positive COVID-19 test by PCR for nasopharyngeal or oropharyngeal swabs (nasopharyngeal swabs are preferred) on the day of the first dose vaccination; 在第一剂疫苗接种当天通过 PCR 对鼻咽或口咽拭子进行 COVID-19 检测呈阳性（首选鼻咽拭子）的受试者;
Subjects who have previously participated in a clinical study of any type of norovirus vaccines within the past year before enrollment in this study; 在参加本研究前的过去一年内曾参加过任何类型诺如病毒疫苗临床研究的受试者;
Subjects with a history of chronic gastrointestinal disorder or having gastroenteritis that required treatment (for example, seek medical advice, etc.) within the past year before screening; or subjects have diarrhea, vomiting, or other digestive system conditions before 2 weeks of the first dose vaccination; 筛选前一年内有慢性胃肠道疾病史或患有需要治疗（例如，寻求医疗建议等）的胃肠炎的受试者;或受试者在第一剂疫苗接种前 2 周内出现腹泻、呕吐或其他消化系统疾病;
Subjects have cancer or have a history of cancer within 5 years before screening; 受试者在筛选前 5 年内患有癌症或有癌症病史;
Subjects with the following conditions: (1) serious congenital malformations, serious developmental disorders, serious genetic defects, serious malnutritions, etc.; (2) thrombocytopenia, coagulation disorder or receipt of anticoagulant therapy, and other contraindications to intramuscular injections; (3) congenital or acquired immunodeficiency or receipt of immunosuppressant therapy (excluding topical treatment, surface treatment for acute non-complicated dermatitis, spray treatment for allergic rhinitis, ICS use for asthma treatmen, etc.) within 6 months; (4) history of infectious diseases, such as tuberculosis; (5) history or family history of convulsions, epilepsy, encephalopathy; (6) asplenia, functional asplenia, and asplenia or splenectomy due to any cause; (7) serious cardiovascular diseases (pulmonary heart disease and pulmonary edema), serious liver and kidney diseases, type I diabetes, celiac disease, autoimmune diseases, etc.; (8) use of medications within the timeframes specified in Section 6.5.2 ; 符合以下条件的受试者： （1） 严重先天畸形、严重发育障碍、严重遗传缺陷、严重营养不良等;（2） 血小板减少症、凝血障碍或接受抗凝治疗，以及肌内注射的其他禁忌症;（3） 6个月内先天性或获得性免疫缺陷或接受免疫抑制剂治疗（不含局部治疗、急性非复杂性皮炎表面治疗、过敏性鼻炎喷雾治疗、哮喘治疗 ICS 使用等）;（4） 传染病史，如肺结核;（5） 抽搐、癫痫、脑病病史或家族史;（6） 无脾、功能性无脾和无脾或因任何原因引起的脾切除术;（7）严重心血管疾病（肺心病和肺水肿）、严重肝肾疾病、I型糖尿病、乳糜泻、自身免疫性疾病等;（8） 在第 6.5.2 节规定的时间范围内使用药物;
Subjects with a clinicallly significant history of serious hypersensitivity to any component of study vaccines, including adjuvant components and yeast, such as allergic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, and local allergic necrotic reaction (Arthus reaction); a history of serious adverse vaccine or drug reactions, such as allergy, urticaria, skin eczema(small, local rashes on a single body part are permitted), dyspnea, and angioedema; 对研究疫苗的任何成分（包括佐剂成分和酵母）具有临床意义的严重超敏反应史的受试者，例如过敏性休克、过敏性喉水肿、过敏性紫癜、血小板减少性紫癜和局部过敏性坏死反应（Arthus 反应）;有严重的疫苗或药物不良反应史，例如过敏、荨麻疹、皮肤湿疹（允许在单个身体部位出现小的局部皮疹）、呼吸困难和血管性水肿;
Subjects with abnormal and clinically significant results of laboratory tests at the discretion of Investigator, such as hematology, serum chemistry, and urinalysis; 研究者酌情决定的实验室检查结果异常且具有临床意义的受试者，例如血液学、血清化学和尿液分析;
Subjects with abnormal and clinically significant ECG results up to the Investigator's discretion at screening; 心电图结果异常且具有临床意义的受试者由研究者在筛选时酌情决定;
Females of childbearing potential with positive serum pregnancy test results; 血清妊娠试验结果呈阳性的育龄女性;
Subjects who are positive for human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), hepatitis C virus (HCV) antibody, or anti-treponema pallidum (anti-TP) antibody at screening; 筛选时人类免疫缺陷病毒 （HIV） 抗体、乙型肝炎表面抗原 （HBsAg）、乙型肝炎核心抗体 （HBcAb）、丙型肝炎病毒 （HCV） 抗体或抗梅毒螺旋体 （anti-TP） 抗体呈阳性的受试者;
Subjects with hypertension (systolic blood pressure 140 mmHg and/or diastolic blood pressure 90 mmHg) or hypotension (systolic blood pressure < 90 mmHg and/or diastolic blood pressure 40 mmHg) (regardless of medication use) in the physical examination before enrollment; 入组前体格检查高血压（收缩压 140 mmHg 和/或舒张压 90 mmHg）或低血压（收缩压 < 90 mmHg 和/或舒张压 40 mmHg）（无论用药）的受试者;
Subjects with fever (oral temperature ≥ 37.5 °C) on the day of vaccination with study vaccines or within 72 h before vaccination; 受试者接种研究疫苗当天或接种前72小时内发热（口腔温度≥37.5°C）;
Subjects who have donated blood or lost blood (≥ 400 mL) or received blood transfusion or used blood products within 30 days before signing the ICF or plan to donate blood during the study(from the first vaccination dose to 3 months after the completion of the vaccination series); 签署 ICF 前 30 天内（从第一剂疫苗接种到疫苗接种系列完成后 3 个月）或接受过输血或使用过血液制品（≥ 400 mL）或接受输血或使用过血液制品或计划在研究期间献血的受试者;
Subjects who have undergone surgery within 3 months before signing the ICF or plan to undergo surgery (including cosmetic surgery, dental surgery, and oral surgery(excluding tooth filling, protaper and tooth extraction)) during the study (from the first vaccination dose to 3 months after the completion of the vaccination series); 签署 ICF 前 3 个月内接受过手术或计划在研究期间（从第一剂疫苗接种到疫苗接种系列后 3 个月）接受手术（包括整容手术、牙科手术和口腔手术（不包括补牙、锥度和拔牙））的受试者;
Smoking more than 10 cigarettes per week within 3 months prior to screening; 筛选前 3 个月内每周吸烟超过 10 支;
History of alcohol abuse within 1 year prior to screening, or regular use of alcohol within 6 months prior to screening that exceeds 14 units of alcohol per week (1 unit = 375 mL of beer 3.5%, 100 mL of wine 13.5%, or 30 mL of spirit 40%); 筛选前 1 年内有酗酒史，或筛选前 6 个月内经常饮酒且每周饮酒超过 14 个单位（1 个单位 = 375 mL 啤酒 3.5%、100 mL 葡萄酒 13.5% 或 30 mL 烈酒 40%）;
History of drug abuse within 1 year prior to screening, or recreational use of soft drugs (such as marijuana) or hard drugs (such as cocaine, phencyclidine [PCP], crack, opioid derivatives including heroin, codeine and amphetamine derivatives) within 1 month prior to screening; 筛选前 1 年内有药物滥用史，或娱乐性使用软性药物（如大麻）或硬性药物（如可卡因、苯环利定 [PCP]、快克、阿片类衍生物，包括海洛因、可待因和苯丙胺衍生物）筛选前 1 个月内;
Subjects with tattoos, scars or skin defects covering the deltoid muscle who are not suitable to participate in the study up to the investigator's discretion; 三角肌上有纹身、疤痕或皮肤缺陷且不适合参加研究的受试者，由研究者自行决定;
Subjects who cannot tolerate venipuncture or have a history of fear of needles or hemophobia; 不能耐受静脉穿刺或有害怕针头或恐血病史的受试者;
Subjects who are not suitable to participate in the study as determined by the investigator . 研究者确定不适合参加研究的受试者。
This section provides details of the study plan, including how the study is designed and what the study is measuring.
本节提供研究计划的详细信息，包括研究的设计方式以及研究的衡量内容。
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Design Details 设计细节
Primary Purpose : Health Services Research 主要目的 ： 卫生服务研究
Allocation : Randomized 分配 ： 随机
Interventional Model : Parallel Assignment 介入模型 ： 平行分配
Interventional Model Description: Parallel Assignment 介入模型说明： 并行赋值
at low dose,150 mg(Cohort 1 ), 20 subjects are dosed Vaccine as experimental at high dose,300mg (Cohort 2), 20 subjects are dosed Vaccine as experimental 低剂量，150 毫克（队列 1），20 名受试者服用高剂量疫苗作为实验性疫苗，300 毫克（队列 2），20 名受试者服用疫苗作为实验性
Incidence of solicited AEs within 7 days after each vaccination dose. 每次疫苗接种后 7 天内请求的 AE 的发生率。
Safety will be assessed through 7 days after vaccination (including the day of vaccination) via collection of solicited AEs.
The solicited AEs include local AEs (injection site: pain,tenderness， induration,swelling,erythema,pruritus)and systemic AEs (Headache, Fatigue,Myalgia,Arthralgia,Vomiting, Diarrhea, Fever). 将通过收集请求的 AE 在接种疫苗后 7 天（包括接种疫苗当天）评估安全性。请求的 AE 包括局部 AE （注射部位：疼痛、压痛、硬结、肿胀、红斑、瘙痒）和全身性 AE （头痛、疲劳、肌痛、关节痛、呕吐、腹泻、发烧）。
7 Days 7 天
Incidence of unsolicited AEs within 28 days after each vaccination dose 每次疫苗接种后 28 天内未经请求的 AE 的发生率
Unsolicited AEs are AEs other than those designated as solicited AEs, and also include eponymous solicited AEs that occur after the solicitation period.
Unsolicited AEs mainly include any AEs that have been reported by the subjects, learned from interrogation or observed by the investigator during the study visits, or discovered during review of medical records or original files.
the incidence of unsolicited AEs within 28 days after each dose of the study vaccine will be calculated. 未经请求的 AE 是指除指定为请求 AE 的 AE 以外的 AE，还包括在请求期之后发生的同名请求 AE。未经请求的 AE 主要包括受试者报告的、从审讯中了解到的或研究者在研究访问期间观察到的，或在审查病历或原始文件时发现的任何 AE。将计算每剂研究疫苗后 28 天内未经请求的 AE 的发生率。
28 Days 28 天
Incidence of AEs related to serum chemistry, hematology, and urinalysis parameters in all subjects on day 4 after each vaccination dose and on day 14, day 42 after the first dose 每次疫苗接种后第 4 天和第一次疫苗接种后第 14 天、第 42 天，所有受试者与血清化学、血液学和尿液分析参数相关的 AE 发生率
The number of participants with any markedly abnormal standard safety laboratory values (serum chemistry,hematology or urinalysis) collected. 收集的标准安全实验室值（血清化学、血液学或尿液分析）明显异常的参与者人数。
42 days 42 天
SAE, MAAE in all subjects within 12 months after the completion of the vaccination series. 所有受试者在疫苗接种系列完成后 12 个月内的 SAE、MAAE。
The subjects will also be monitored for SAEs, MAAEs from the first dose to 12 months after the completion of the vaccination series. 还将从第一剂到疫苗接种系列完成后 12 个月监测受试者的 SAE、MAAE。
GMT is geometric mean titer.
HBGA is Histo-blood group antigen.
Predose 0 and 7, 14, 28 days after the first and second dose, and 7, 14, 28 days, 3, 6, 12 months after completion of full vaccination (up to Day 421) GMT 是几何平均滴度。HBGA 是组织血型抗原。第一剂和第二剂后第 0 天和第 7、14、28 天，以及完成完全疫苗接种后第 7、14、28 天、3、6、12 个月（直至第 421 天）
GMFR is geometric mean fold rise.
Predose 0 and 7, 14, 28 days after the first and second dose, and 7, 14, 28 days, 3, 6, 12 months after completion of full vaccination (up to Day 421) GMFR 是几何平均弃牌率上升。第一剂和第二剂后第 0 天和第 7、14、28 天，以及完成完全疫苗接种后第 7、14、28 天、3、6、12 个月（直至第 421 天）
SCR is Seroconversion rate.
Seroconversion is defined as: For the subject whose antibody titer is below the lower limit of quantification before vaccination, the antibody titer is increased to the lower limit of quantification or above after vaccination; for the subject whose antibody titer is at the lower limit of quantification or above before vaccination, the antibody titer is increased at least 4-fold after vaccination.
Predose 0 and 7, 14, 28 days after the first and second dose, and 7, 14, 28 days, 3, 6, 12 months after completion of full vaccination SCR 是血清转化率。血清转化定义为： 对于接种疫苗前抗体滴度低于定量下限的受试者，接种疫苗后抗体滴度增加到定量下限或以上;对于接种疫苗前抗体滴度处于定量下限或以上的受试者，接种疫苗后抗体滴度至少增加 4 倍。给药前 第一剂和第二剂后 0 天和 7、14、28 天，以及完成完全疫苗接种后 7、14、28 天、3、6、12 个月
predose 0 and 7, 14, 28 days after the first and second dose, and 7, 14, 28 days, 3, 6, 12 months after completion of full vaccination 给药前 第一剂和第二剂后 0 天和 7、14、28 天，以及完成完全疫苗接种后 7、14、28 天、3、6、12 个月
Predose 0 and 7, 14, 28 days after the first and second dose, and 7, 14, 28 days, 3, 6, 12 months after completion of full vaccination 给药前 第一剂和第二剂后 0 天和 7、14、28 天，以及完成完全疫苗接种后 7、14、28 天、3、6、12 个月
Predose 0 and 7, 14, 28 days after the first and second dose, and 7, 14, 28 days, 3, 6, 12 months after completion of full vaccination 给药前 第一剂和第二剂后 0 天和 7、14、28 天，以及完成完全疫苗接种后 7、14、28 天、3、6、12 个月
12 Months 12 个月
GMT of Serum Anti-norovirus GI.1 and GII.2, GII.3, GII.4, GII.6, GII.17 VLP IgA 血清抗诺如病毒 GI.1 和 GII.2、GII.3、GII.4、GII.6、GII.17 VLP IgA 的 GMT
Predose 0 and 7, 14, 28 days after the first and second dose, and 7, 14, 28 days, 3, 6, 12 months after completion of full vaccination 给药前 第一剂和第二剂后 0 天和 7、14、28 天，以及完成完全疫苗接种后 7、14、28 天、3、6、12 个月
12 Months 12 个月
GMFR of Serum Anti-norovirus GI.1 and GII.2, GII.3, GII.4, GII.6, GII.17 VLP IgA 血清抗诺如病毒 GI.1 和 GII.2、GII.3、GII.4、GII.6、GII.17 VLP IgA 的 GMFR
Predose 0 and 7, 14, 28 days after the first and second dose, and 7, 14, 28 days, 3, 6, 12 months after completion of full vaccination 给药前 第一剂和第二剂后 0 天和 7、14、28 天，以及完成完全疫苗接种后 7、14、28 天、3、6、12 个月
12 Months 12 个月
SCR of Serum Anti-norovirus GI.1 and GII.2, GII.3, GII.4, GII.6, GII.17 VLP IgA 血清抗诺如病毒 GI.1 和 GII.2、GII.3、GII.4、GII.6、GII.17 VLP IgA 的 SCR
Predose 0 and 7, 14, 28 days after the first and second dose, and 7, 14, 28 days, 3, 6, 12 months after completion of full vaccination 给药前 第一剂和第二剂后 0 天和 7、14、28 天，以及完成完全疫苗接种后 7、14、28 天、3、6、12 个月
Predose 0 and 7, 14, 28 days after the first and second dose, and 7, 14, 28 days, 3, 6, 12 months after completion of full vaccination 给药前 第一剂和第二剂后 0 天和 7、14、28 天，以及完成完全疫苗接种后 7、14、28 天、3、6、12 个月
predose 0 and 7, 14, 28 days after the first and second dose, and 7, 14, 28 days, 3, 6, 12 months after completion of full vaccination 给药前 第一剂和第二剂后 0 天和 7、14、28 天，以及完成完全疫苗接种后 7、14、28 天、3、6、12 个月
Predose 0 and 7, 14, 28 days after the first and second dose, and 7, 14, 28 days, 3, 6, 12 months after completion of full vaccination 给药前 第一剂和第二剂后 0 天和 7、14、28 天，以及完成完全疫苗接种后 7、14、28 天、3、6、12 个月
12 Months 12 个月
Norovirus-specific T-cell IFN-γ,IL-2, IL-4 and IL-10 levels In the high dose group. 诺如病毒特异性 T 细胞 IFN-γ、IL-2、IL-4 和 IL-10 水平在高剂量组中。
Predose 0 and 7, 28 days after completion of full vaccination 给药前 0 和 7，完成完全疫苗接种后 28 天
28 Days 28 天
Collaborators and Investigators 合作者和调查者
This is where you will find people and organizations involved with this study. 在这里，您可以找到参与这项研究的个人和组织。
Principal Investigator:Kristi McLendon, Dr,Q-Pharm Pty Ltd 首席研究员：Kristi McLendon，Dr，Q-Pharm Pty Ltd
Study Record Dates 学习记录日期
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website. 这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。美国国家医学图书馆 （NLM） 会审查研究记录和报告的结果，以确保它们符合特定的质量控制标准，然后再发布到公共网站上。
Study Registration Dates 学习注册日期
First Submitted 首次提交
2023-02-23
First Submitted that Met QC Criteria 首次提交符合 QC 标准的
2023-03-27
First Posted 首次发布
2023-04-10
Study Record Updates 研究记录更新
Last Update Submitted that met QC Criteria 最后更新：提交符合 QC 标准
