A Study Assessing the Efficacy and Safety of HS-10380 in Hospitalized Adults With Acute Schizophrenia

Summary

This is a Phase 2b, randomized, double-blind, parallel-group, active-controlled and placebo-controlled, multicenter inpatient study to examine the efficacy and safety of HS-10380 in adult Participants who are acutely psychotic with a Diagnostic and Statistical Manual Fifth Edition (DSM-5) diagnosis of schizophrenia. The primary objective of the study is to assess the efficacy of HS-10380 versus placebo in reducing Positive and Negative Syndrome Scale (PANSS) total scores in adult inpatients with a DSM-5 diagnosis of schizophrenia. The secondary objectives of the study are to evaluate the response rate, improvement in disease severity and symptoms, safety and tolerability, and pharmacokinetics.

Timeline

Start

2024-05-23

Primary completion

2026-01-02

Completion

2026-01-19

Drugs

Indications