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Phase Ⅰb/Ⅱ Study of HS-10506 in Chinese Participants With Insomnia Disorder

NCT06279286 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 312

Last updated 2024-04-23

No results posted yet for this study

Summary

The primary purpose of this phase Ⅰb/Ⅱ study is to investigate the safety, tolerability, pharmacokinetics (the study of the way a drug enters and leaves the blood and tissues over time) after multiple dose administration and the efficacy of HS-10506 (change versus placebo) on latency to persistent sleep (LPS) measured by polysomnography (PSG) in Chinese adult participants with insomnia disorder.

Conditions

  • Insomnia Disorder

Interventions

DRUG

HS-10506

HS-10506, tablets (10mg, 20mg, 40mg and 80mg) at night once daily from Day 1 to Day 5 in phase Ib study, and from Day 1 to Day 28 in phase II study.

DRUG

Placebo

Placebo, placebo tablets matching the HS-10506 tablets

Sponsors & Collaborators

  • Jiangsu Hansoh Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2024-05-31
Primary Completion
2025-01-31
Completion
2025-01-31

Countries

  • China

Study Locations

More Related Trials

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 NCT06279286 on ClinicalTrials.gov