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NOT YET RECRUITING
NCT07759869
PHASE3

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

Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

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.

Official title: A Multicenter, Open-label, Phase 3 Study to Evaluate the Long-term Safety of HS-10380 in Chinese Adult Patients With Schizophrenia

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

500

Start Date

2026-09-09

Completion Date

2028-08-31

Last Updated

2026-08-12

Healthy Volunteers

No

Interventions

DRUG

HS-10380

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

Locations (1)

Peking University Sixth Hospital

Beijing, Beijing Municipality, China