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

NCT07550387 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 363

Last updated 2026-04-24

No results posted yet for this study

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.

Conditions

  • SCHIZOPHRENIA 1 (Disorder)

Interventions

DRUG

HS-10380 Low Dose

W1：dose titration; W 2-3 dose adjust to optimal level；Week 4-6：stable dose

DRUG

HS-10380 Medium dose

W1: dose titration; W 2-3: dose adjust to optimal level; Week 4-6: stable dose

DRUG

HS-10380 High Dose

W1: dose titration; W 2-3: dose adjust to optimal level; Week 4-6: stable dose

DRUG

Aripiprazole

W1: dose titration; W 2-3: dose adjust to optimal level; Week 4-6: stable dose

DRUG

Placebo

W1: dose titration; W 2-3: dose adjust to optimal level; Week 4-6: stable dose

Sponsors & Collaborators

  • Jiangsu Hansoh Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-23
Primary Completion
2026-01-02
Completion
2026-01-19

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07550387 on ClinicalTrials.gov