NCT06279286

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

A Randomized, Double-blind, Placebo-controlled Phase Ⅰb/Ⅱ Study to Investigate the Safety, Tolerability, Pharmacokinetics and Efficacy of HS-10506 in Chinese Adult Participants With Insomnia Disorder

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 312 (estimated)
• Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study consists of two stages: phase Ib and phase II. Primary objective of phase Ib Study is to assess the safety, tolerability of HS-10506 in subjects with insomnia disorder. . Primary objective of phase II Study is to assess the efficacy of HS-10506 in subjects with insomnia disorder.

Conditions

• Insomnia Disorder

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-05-01
• Primary completion: 2025-01-01
• Completion: 2025-01-01
• First posted: 2024-02-28
• Last updated: 2024-04-23

Locations

1 site across 1 country: China