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A Study to Evaluate the Long-term Safety of HS-10380 in Patients With Schizophrenia

NCT07759869 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2026-08-12

No results posted yet for this study

Summary

The primary purpose of this open-label phase 3 study is to evaluate the safety of HS-10380 on the incidence, severity, relationship to investigational product of adverse events (AE), serious adverse events (SAE), and adverse events leading to study drug discontinuationin Chinese adult participants with schizophrenia.

Conditions

  • SCHIZOPHRENIA 1 (Disorder)

Interventions

DRUG

HS-10380

Oral;QD;W1:dose titration; W1-2:dose adjust to optimal level;Week 3-52:stable dose.

Sponsors & Collaborators

  • Jiangsu Hansoh Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2026-09-09
Primary Completion
2028-07-31
Completion
2028-08-31

Countries

  • China

Study Locations

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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 NCT07759869 on ClinicalTrials.gov