NCT05964790

Safety, Tolerability, Pharmacokinetics and Efficacy Study of HS-10380 in Patients With Schizophrenia

A Phase Ⅰb/Ⅱ, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Investigate the Safety, Tolerability, Pharmacokinetics and Efficacy of HS-10380 in Chinese Adults With Schizophrenia.

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 112 (estimated)
• Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to evaluate the safety, tolerability, pharmacokinetics and efficacy of HS-10380 relative to placebo for the treatment of participants with schizophrenia.

Detailed description

The trial consists of two parts: dose escalation cohorts and expansion cohorts. The primary aim of the dose escalation cohorts is to evaluate the safety and tolerability of HS-10380 in participants with schizophrenia, and the primary aim of expansion cohorts is to evaluate efficacy of HS-10380 in participants with schizophrenia.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	HS-10380	Participants in arm HS-10380 will receiving multiple ascending doses of HS-10380 (1.5 mg initial dose) orally once daily for 28 days
DRUG	Placebo	Participants in arm Placebo will receiving multiple ascending doses of Placebo matching HS-10380 (1.5 mg initial dose) orally once daily for 28 days

Timeline

• Start date: 2023-07-30
• Primary completion: 2024-06-30
• Completion: 2024-12-30
• First posted: 2023-07-28
• Last updated: 2023-07-28