Safety and Efficacy Study of YZJ-1139 in Insomnia Disorder

June 29, 2026 updated by: Shanghai Haiyan Pharmaceutical Technology Co., Ltd.

A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter, Phase 3 Clinical Study to Evaluate the Efficacy and Safety of YZJ-1139 Tablets in the Treatment of Insomnia Disorder

The main purpose of this study is to assess efficacy and safety of YZJ-1139 in adult subjects with insomnia disorder. Efficacy will be evaluated on objective and subjective sleep parameters.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

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.

Intervention / Treatment

Intervention / Treatment

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1037

Phase

Phase

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.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

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.

Study Locations

  • China
      • Beijing, China
        • Peking University First Hospital
      • Beijing, China
        • Peking University People's Hospital
      • Beijing, China
        • China-Japan Friendship Hospital
      • Beijing, China
        • Xuanwu Hospital Capital Medical University
      • Beijing, China
        • Beijing Tsinghua Changgung Hospital
      • Beijing, China
        • Beijing Chao-Yang Hospital, Capital Medical University
      • Beijing, China
        • Beijing Tiantan Hospital, Capital Medical University
      • Beijing, China
        • Beijing Hui Long Guan Hospital, Capital Medical University
      • Bengbu, China
        • The First Affiliated Hospital of Bengbu Medical College
      • Binzhou, China
        • Binzhou Medical University Hospital
      • Changchun, China
        • The First Bethune Hospital of Jilin University
      • Changsha, China
        • Xiangya Hospital Central South University
      • Changsha, China
        • The First Hospital of Changsha
      • Changsha, China
        • The Second XiangYa Hospital Of Central University
      • Changsha, China
        • The Secong People's Hospital Of HuNan Province
      • Chengdu, China
        • The Fourth People's Hospital of Chengdu
      • Chongqing, China
        • Army Medical Center of PLA
      • Chongqing, China
        • Chongqing University Three Gorges Hospital
      • Chongqing, China
        • ChongQing Mental Health Center
      • Chongqing, China
        • ChongQing Eleventh People's Hospital
      • Chongqing, China
        • ChongQing Traditional Chinese Medical Hospital
      • Deyang, China
        • People's Hospital of Deyang City
      • Fuzhou, China
        • The First Affiliated Hospital Of FuJan Medical University
      • Guangzhou, China
        • Guangdong Provincial People's Hospital
      • Guangzhou, China
        • Nanfang Hospital Southern Medical University
      • Guangzhou, China
        • The First Affiliated Hospital of Jinan University
      • Guiyang, China
        • The Affiliated Hospital of Guizhou Medical University
      • Handan, China
        • Handan Central Hospital
      • Hangzhou, China
        • Sir Run Run Shaw Hospital
      • Hangzhou, China
        • Affiliated HangZhou First People's Hospital
      • Ha’erbin, China
        • The 2nd Affiliated Hospital of Harbin Medical University
      • Hefei, China
        • The Second Hospital of Anhui Medical University
      • Hefei, China
        • Chaohu Hospital of Anhui Medical University
      • Hefei, China
        • The Secong People's Hospital Of HeFei
      • Hengyang, China
        • Affiliated NanHua Hospital,University Of South China
      • Jiangmen, China
        • Jiangmen Central Hospital
      • Jinan, China
        • Shandong Provincial Qianfoshan Hospital
      • Jingjiang, China
        • Jingjiang People's Hospital
      • Jining, China
        • Shandong Daizhuang Hospital
      • Jiujiang, China
        • Jiujiang University Affiliated Hospital
      • Kunming, China
        • First People's Hospital of Yunnan Province
      • Liaocheng, China
        • Liaocheng People's Hospital
      • Luoyang, China
        • HeNan University Of Science &Technology
      • Luzhou, China
        • The Affiliated hospital of Southwest Medical University
      • Nanchang, China
        • The First Affiliated Hospital of Nanchang University
      • Nanchang, China
        • The Second Affiliated Hospital of Nanchang University
      • Nanchang, China
        • Jiangxi Provincial People's Hospital
      • Nanjing, China
        • Zhongda Hospital Southeast Unveristy
      • Nantong, China
        • Nantong First People's Hospital
      • Ningbo, China
        • Ningbo Medical Center Lihuili Hospital
      • Ningbo, China
        • NingBo KangNing Hospital
      • Qingdao, China
        • Qingdao Municipal Hospital
      • Qingdao, China
        • The affilated hospital of qingdao university
      • Qingdao, China
        • QingDao Center Medical Group
      • Quanzhou, China
        • The 2nd Affiliated Hospital Of FuJan Medical University
      • Shanghai, China
        • Huashan Hospital Fudan University
      • Shanghai, China
        • Affiliated ZhongShan Hospital,University Of FuDan
      • Shenyang, China
        • Shengjing Hospital of China Medical University
      • Shenzhen, China
        • Shenzhen People's Hospital
      • Shijiazhuang, China
        • The First Hospital of Hebei Medical University
      • Shijiazhuang, China
        • The Third Hospital of Hebei Medical University
      • Siping, China
        • Jilin Neuropsychiatric Hospital
      • Suzhou, China
        • The Second Affiliated Hospital of Soochow University
      • Suzhou, China
        • Suzhou Guangji Hospital
      • Suzhou, China
        • The First People's Hospital of Kunshan
      • Taiyuan, China
        • First Hospital of Shanxi Medical University
      • Tianjin, China
        • Peking University BinHai Hospital
      • Tianjin, China
        • Tianjin Huanhu Hospital
      • Tianjin, China
        • Tianjin Mental Health Center
      • Wuhan, China
        • The Center Hospital of WuHan
      • Wuhan, China
        • Wuhan Mental Health Centre
      • Wuxi, China
        • Wuxi People's Hospital
      • Wuxi, China
        • Affiliated Hospital of Jiangnan University
      • Xi'an, China
        • Air Force Medical University
      • Xianyang, China
        • Xianyang Hospital of Yan'an University
      • Xinxiang, China
        • HeNan Mental Hospital
      • Xuzhou, China
        • The Affiliated Hospital of Xuzhou Medical University
      • Xuzhou, China
        • Xuzhou Central Hospital
      • Zhengzhou, China
        • The First Affiliated Hospital Of ZhenZhou University
      • Zhengzhou, China
        • ZhenZhou Central Hospital
      • Zhenjiang, China
        • Zhenjiang Mental Health Center
      • Zhumadian, China
        • Zhumadian Second People's Hospital
      • Zigong, China
        • Zigong First People's Hospital

Participation Criteria

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.

Eligibility Criteria

Eligibility Criteria

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.

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

- Subjects who meet all of the following criteria may be enrolled in the study:

  1. Aged ≥ 18 to < 65 years.
  2. Meet the clinical diagnostic criteria for insomnia disorder as defined in International Classification of Sleep Disorders, 3rd Edition (ICSD-3) criteria.
  3. sTSO ≥ 30 min for at least 3 nights per week and/or sWASO ≥ 60 min for at least 3 nights per week within 28 days (4 weeks) prior to screening.
  4. During the run-in period or on Day 1 of the treatment period, sTSO ≥ 30 min for at least 3 nights in the last 7 sleep diaries and/or sWASO ≥ 60 min for at least 3 nights out of 7 nights as confirmed by the sleep diary prior to Polysomnography (PSG) monitoring.

  5. PSG results for 2 consecutive nights during the run-in period should meet the following conditions:

    • The mean LPS of 2 nights is ≥ 30 min, with the LPS ≥ 20 min for any night;
    • And/or the mean WASO of 2 nights is ≥ 60 min, with neither night < 45 min;
    • The mean SE of 2 nights is ≤ 85%, with the SE ≤ 87.5% for both nights.
  6. ISI score ≥ 15 at screening and on Day 1 of the treatment period.
  7. Agree to follow the habitual bedtime between 9 p.m. and 1 a.m., wake up between 5 a.m. and 10 a.m. every day, and stay in bed for 6.5 to 9 hours per night during the study.
  8. Have a bedtime between 9 p.m. and 1 a.m., wake up between 5 a.m. and 10 a.m., and stay in bed for 6.5 to 9 hours for at least 5 days in the last 7 sleep diaries as confirmed by the sleep diary prior to PSG monitoring during the run-in period or on Day 1 of the treatment period.
  9. Female subjects are confirmed to be non-pregnant at screening; both men of reproductive potential and women of childbearing potential should agree to use medically acceptable and effective contraception throughout the study and within 3 months after the end of the study.
  10. Understand the study procedures and contents, voluntarily participate in the clinical study and sign the written Informed Consent Form (ICF), have good compliance during participation in the study, and are willing to attend the visits.

Exclusion Criteria:

  • Subjects who meet any of the following criteria should be excluded from this study:

    1. Depression: Hamilton Depression Scale (HAMD) score ≥ 18; anxiety: Hamilton Anxiety Scale (HAMA) score ≥ 14.
    2. Suicidal ideation with or without plan at screening or within 6 months prior to screening (score ≥ 3 on item 3 [suicide] of HAMD, or select "Yes" on item 3, 4 or 5 of suicidal ideation subscale of Columbia-Suicide Severity Rating Scale (C-SSRS)), or have any suicidal behavior in the past 10 years (as assessed by the suicidal ideation subscale of C-SSRS).
    3. Apnea-hypopnea index (AHI) and/or periodic limb movement index (PLMI) > 10 times/hour detected by PSG monitoring during the run-in period.
    4. Repeat electrocardiogram (ECG) at screening shows QTcF interval prolongation (QTcF > 450 ms) (the ECG should be repeated 2 more times only if the initial ECG shows QTcF interval > 450 ms).
    5. Have serious endocrine diseases, hematological diseases, cardiovascular and cerebrovascular diseases, gastrointestinal diseases, liver and kidney diseases, autoimmune diseases, impaired respiratory function or other related diseases, or have other medical history that may affect the safety of the subjects or interfere with the study assessments in the opinion of the investigator.
    6. Have insomnia disorder due to other causes such as chronic pain, headache, eczema, neurodermatitis, allergic rhinitis, and serious dermatitis (difficulty sleeping due to physical reasons, difficulty falling asleep due to medical reasons).
    7. Previous history of nervous system disorders such as epilepsy, schizophrenia, bipolar mental disorder, neurodevelopmental retardation, and cognitive disorder, or previous history of other mental illness that may affect the safety of the subjects or interfere with the study assessments in the opinion of the investigator.
    8. Previous history of sleep-related respiratory disorders including obstructive sleep apnea (with or without continuous positive airway pressure (CPAP) therapy), periodic limb movement disorder, restless legs syndrome, circadian rhythm sleep disturbances, narcolepsy or other sleep disorders: subjects with restless legs syndrome which is diagnosed by relevant diagnostic and treatment guidelines should be excluded.
    9. Have previous complex sleep behaviors, such as sleep driving, sleep eating, and sleep phone calls.
    10. Plan to undergo surgery during the study.
    11. Have received any hypnotics, antidepressants, antipsychotic drugs, anticholinergics, memory-enhancing drugs, antihistamines, centrally acting analgesics, centrally acting muscle relaxants, central nervous system stimulants, cytochrome P450 3A (CYP3A) inducers, CYP3A inhibitors, traditional Chinese medicines and traditional Chinese medicinal products with sleep-improving effects, or any other therapies for insomnia disorder within 1 week prior to the run-in period or within 5 half-lives of the investigational product, whichever is longer.
    12. History of drug taking or addiction, which is known through questioning.
    13. Have any lifestyle that interferes with the study process or may interfere with sleep: for example, there will be travels across 3 or more time zones (mainland China is considered as 1 time zone) within the next 2 weeks or during the study period, or there will be shift work (night and daytime shift).
    14. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) > 2 × the upper limit of normal (ULN), or Creatinine (Cr) > 1.5 × ULN.
    15. Hyperthyroidism.
    16. History of alcohol abuse (defined as regular daily alcohol consumption exceeding the following criteria: approximately 720 mL of beer, or 240 mL of wine, or 60 mL of liquor) within the past 2 years.
    17. History of drug abuse within the past 2 years, or positive urine drug screening for any indicator.
    18. Regular daily consumption of excessive tea and coffee drinks (defined as consumption of > 4 cups of caffeinated beverages or > 400 mg of caffeine per day), or daily habituation to drinking caffeinated beverages beyond 18:00.
    19. Have nocturia increased caused by urinary tract infection, urinary tract injury or prostatic disorder.
    20. Have positive infectious disease screening for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCVAb) and human immunodeficiency virus (HIV) antibody at screening.
    21. Unable to avoid vaccination within 1 month prior to screening or during the first treatment phase.
    22. Have participated in clinical studies of other drugs within the past 1 month or 5 half-lives (whichever is longer), or plan to participate in other studies simultaneously during participation in this study.
    23. Pregnant or lactating women.
    24. History of allergy to the investigational product or its components.
    25. Have prior participation in clinical studies of YZJ-1139 Tablets.
    26. Have other conditions that make the subject unsuitable for participation in the clinical study in the opinion of the investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

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.
Intervention / Treatment

Intervention / Treatment

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.
Placebo Comparator: Placebo
Drug: Placebo
Match placebo tablets, once daily in the evening
Experimental: YZJ-1139 20mg
Drug: YZJ-1139 20mg
YZJ-1139 20mg tablets, once daily in the evening
Experimental: YZJ-1139 40mg
Drug: YZJ-1139 40mg
YZJ-1139 40mg tablets, once daily in the evening

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

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.
Outcome Measure
Measure Description
Time Frame
Change from baseline in the subjective sleep efficiency (sSE) after 14 days of treatment
Time Frame: from baseline to week 2
Subjective Sleep efficiency variation assessed by the sleep diary questionnaire at 14 days of treatment from baseline. A positive change from baseline indicates an increase in the subjective Sleep efficiency. A negative change from baseline indicates a decrease in subjective Sleep efficiency
from baseline to week 2
Change from baseline in the sleep efficiency (SE) after 14 days of treatment
Time Frame: from baseline to day 14
Sleep efficiency variation assessed by polysomnography at 14 days of treatment from baseline. A positive change from baseline indicates an increase in the Sleep efficiency. A negative change from baseline indicates a decrease in Sleep efficiency
from baseline to day 14

Secondary Outcome Measures

Secondary Outcome Measures

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.
Outcome Measure
Measure Description
Time Frame
Change from baseline in the subjective sleep efficiency (sSE) after 7 days of treatment
Time Frame: Baseline, week 1
sSE is self-reported sleep outcome measured by subject diary data, collected daily and analyzed at appropriate intervals.
Baseline, week 1
Changes from baseline in the Subjective time to sleep onset (sTSO) after 14 days of treatment for subjects entering the second treatment phase
Time Frame: Baseline, week 1, week 2
sTSO are self-reported sleep outcome measured by subject diary data, collected daily and analyzed at appropriate intervals.
Baseline, week 1, week 2
Changes from baseline in the Subjective wake after sleep onset (sWASO) after 14 days of treatment for subjects entering the second treatment phase
Time Frame: Baseline, week 1, week 2
sWASO are self-reported sleep outcome measured by subject diary data, collected daily and analyzed at appropriate intervals.
Baseline, week 1, week 2
Changes from baseline in the Subjective total sleep time (sTST) after 14 days of treatment for subjects entering the second treatment phase
Time Frame: Baseline, week 1, week 2
sTST are self-reported sleep outcome measured by subject diary data, collected daily and analyzed at appropriate intervals.
Baseline, week 1, week 2
Changes from baseline in the Subjective number of awakenings (sNAW) after 14 days of treatment for subjects entering the second treatment phase
Time Frame: Baseline, week 1, week 2
sNAW are self-reported sleep outcome measured by subject diary data, collected daily and analyzed at appropriate intervals.
Baseline, week 1, week 2
Changes from baseline in the SE after 2 days of treatment
Time Frame: Baseline, Day1/Day2
SE assessed by polysomnography at 2 days of treatment from baseline. A positive change from baseline indicates an increase in the Sleep efficiency. A negative change from baseline indicates a decrease in Sleep efficiency
Baseline, Day1/Day2
Latency to persistent sleep (LPS) after 2 and 14 days of treatment
Time Frame: Baseline, Day1/Day2, Day13/Day14
LPS assessed by polysomnography at 2 and 14 days of treatment from baseline. A positive change from baseline indicates an increase in the Sleep efficiency. A negative change from baseline indicates a decrease in Sleep efficiency
Baseline, Day1/Day2, Day13/Day14
Wake after sleep onset (WASO) after 2 and 14 days of treatment
Time Frame: Baseline, Day1/Day2, Day13/Day14
WASO assessed by polysomnography at 2 and 14 days of treatment from baseline. A positive change from baseline indicates an increase in the Sleep efficiency. A negative change from baseline indicates a decrease in Sleep efficiency
Baseline, Day1/Day2, Day13/Day14
Total sleep time (TST) after 2 and 14 days of treatment
Time Frame: Baseline, Day1/Day2, Day13/Day14
TST assessed by polysomnography at 2 and 14 days of treatment from baseline. A positive change from baseline indicates an increase in the Sleep efficiency. A negative change from baseline indicates a decrease in Sleep efficiency
Baseline, Day1/Day2, Day13/Day14
Sleep structure (wakefulness, N1, N2, N3, rapid eye movement sleep [REM], non-rapid eye movement sleep [NREM], REM latency, number of awakenings [NAW], arousal index for REM and NREM) after 2 and 14 days of treatment
Time Frame: Baseline, Day1/Day2, Day13/Day14
Sleep structure assessed by polysomnography at 2 and 14 days of treatment from baseline.
Baseline, Day1/Day2, Day13/Day14
Change from baseline in the mean subjective sleep quality score after 7 and 14 days of treatment for subjects
Time Frame: Baseline, Week 1, Week 2
Subjective sleep quality score is a self-report assessment of participant perception of the effects of a medication on their sleep. Higher score indicated severe insomnia problem.
Baseline, Week 1, Week 2
Percentage of Participants on each scale of Global Impression of Insomnia (PGI-I) each Item at 14 days of treatment
Time Frame: Day 14
The PGI-I was a self-report assessment of participant perception of the effects of a medication on their sleep. The PGI-I had 3 items related to study medication effects (a) helped/worsened sleep, (b) decreased/increased time to fall asleep, (c) increased/decreased total sleep time, and 1 item related to perceived appropriateness of study medication strength. The first 3 items were answered on a 3-point scale (1=positive medication effect, 2=neutral medication effect, 3=negative medication effect) and the last item on a different 3 point scale (medication: 1=too strong, 2=just right, 3=too weak)
Day 14
Changes from baseline in the sSE after 30, 90 and 180 days of treatment for subjects entering the second treatment phase
Time Frame: Baseline, Day 30, Day 90, and Day 180
sSE are self-reported sleep outcome measured by subject diary data, collected daily and analyzed at appropriate intervals.
Baseline, Day 30, Day 90, and Day 180
Changes from baseline in the sTSO after 30, 90 and 180 days of treatment for subjects entering the second treatment phase
Time Frame: Baseline, Day 30, Day 90, and Day 180
sTSO are self-reported sleep outcome measured by subject diary data, collected daily and analyzed at appropriate intervals.
Baseline, Day 30, Day 90, and Day 180
Changes from baseline in the sWASO after 30, 90 and 180 days of treatment for subjects entering the second treatment phase
Time Frame: Baseline, Day 30, Day 90, and Day 180
sWASO are self-reported sleep outcome measured by subject diary data, collected daily and analyzed at appropriate intervals.
Baseline, Day 30, Day 90, and Day 180
Changes from baseline in the sTST after 30, 90 and 180 days of treatment for subjects entering the second treatment phase
Time Frame: Baseline, Day 30, Day 90, and Day 180
sTST are self-reported sleep outcome measured by subject diary data, collected daily and analyzed at appropriate intervals.
Baseline, Day 30, Day 90, and Day 180
Changes from baseline in the sNAW after 30, 90 and 180 days of treatment for subjects entering the second treatment phase
Time Frame: Baseline, Day 30, Day 90, and Day 180
sNAW are self-reported sleep outcome measured by subject diary data, collected daily and analyzed at appropriate intervals.
Baseline, Day 30, Day 90, and Day 180
Change from baseline in the mean subjective sleep quality score after 30, 90 and 180 days of treatment for subjects entering the second treatment phase
Time Frame: Baseline, Day 30, Day 90, and Day 180
Subjective sleep quality score is a self-report assessment of participant perception of the effects of a medication on their sleep. Higher score indicated severe insomnia problem.
Baseline, Day 30, Day 90, and Day 180
Change from baseline in the Insomnia Severity Index (ISI) score after 30, 90 and 180 days of treatment for subjects entering the second treatment phase
Time Frame: Baseline, Day 30, Day 90, and Day 180
ISI is a self-report questionnaire assessing the nature, severity, and impact of insomnia. Higher score indicated severe insomnia problem.
Baseline, Day 30, Day 90, and Day 180
Percentage of Participants who enter the second treatment phase on each scale of Patient Global Impressions - ImprovementGlobal Impression of Insomnia (PGI-I) each Item at 30, 90 and 180 days of treatment
Time Frame: Day 30, Day 90, and Day 180
The PGI-I was a self-report assessment of participant perception of the effects of a medication on their sleep. The PGI-I had 3 items related to study medication effects (a) helped/worsened sleep, (b) decreased/increased time to fall asleep, (c) increased/decreased total sleep time, and 1 item related to perceived appropriateness of study medication strength. The first 3 items were answered on a 3-point scale (1=positive medication effect, 2=neutral medication effect, 3=negative medication effect) and the last item on a different 3 point scale (medication: 1=too strong, 2=just right, 3=too weak).
Day 30, Day 90, and Day 180

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai Haiyan Pharmaceutical Technology Co., Ltd.

Study record dates

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.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 17, 2021

Primary Completion (Actual)

Primary Completion

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 "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 7, 2023

Study Completion (Actual)

Study Completion

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 "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 27, 2023

Study Registration Dates

First Submitted

First Submitted

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).
August 24, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

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.
August 31, 2022

First Posted (Actual)

First Posted

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.
September 1, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

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.
June 30, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

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.
June 29, 2026

Last Verified

Last Verified

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.
June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

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.
  • YZJ-1139-3-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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