drugset / Trial / NCT06279286

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

NCT06279286 ↗

Phase 1/2 Unknown 312 enrolled Jiangsu Hansoh Pharmaceutical Co., Ltd.
RandomizedSequentialDouble-blindTreatment

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject HS-10506 Unknown 10 mg —
Subject HS-10506 Unknown 20 mg —
Subject HS-10506 Unknown 40 mg —
Subject HS-10506 Unknown 80 mg —

Indications