Clinical Trial

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

Completed Phase 2
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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.
Trial Details
NCT Number NCT07550387
Lead Sponsor Jiangsu Hansoh Pharmaceutical Co., Ltd.
Conditions SCHIZOPHRENIA 1 (Disorder)
Enrollment 363 participants
Start Date 2024-05-23
Primary Completion 2026-01-02 (estimated)
Study Completion 2026-01-19 (estimated)
Updated on ClinicalTrials.gov 2026-04-24