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Safety and Efficacy Study of YZJ-1139 in Insomnia Disorder

NCT05525637 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1041

Last updated 2024-04-18

No results posted yet for this study

Summary

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.

Conditions

  • Insomnia Disorder

Interventions

DRUG

YZJ-1139 20mg

YZJ-1139 20mg tablets, once daily in the evening

DRUG

YZJ-1139 40mg

YZJ-1139 40mg tablets, once daily in the evening

DRUG

Placebo

Match placebo tablets, once daily in the evening

Sponsors & Collaborators

  • Shanghai Haiyan Pharmaceutical Technology Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-17
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • China

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05525637 on ClinicalTrials.gov