NCT05480592

A Study of HS-10380 in Chinese Participants

A Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Phase I Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of HS-10380 in Chinese Healthy Adult Subjects

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 76 (estimated)
• Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The primary objective of this study is to assess the safety and tolerability of single and multiple oral administered doses of HS-10380 in Chinese healthy subjects.

Detailed description

This is a phase I, randomized, double-blinded, placebo-controlled, both single ascending doses (SAD) study and multiple ascending dose (MAD) clinical trial to assess the safety, tolerability, and pharmacokinetics of HS-10380 in Chinese healthy subjects. There will be four phases in SAD and MAD study: a 2-week screening phase, a 1-day baseline phase, a double-blind treatment phase, and a 1-week post-treatment (follow-up) phase.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	HS-10380	Administered orally as a tablet
DRUG	Placebo	Administered orally as a tablet

Timeline

• Start date: 2022-08-01
• Primary completion: 2023-06-30
• Completion: 2023-07-30
• First posted: 2022-07-29
• Last updated: 2023-03-09

Locations

1 site across 1 country: China