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

Insomnia Disorder Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06279286
Study type Interventional
Source Jiangsu Hansoh Pharmaceutical Co., Ltd.
Contact
Status Not yet recruiting
Phase Phase 1/Phase 2
Start date May 2024
Completion date January 2025
View Details
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