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A Study to Evaluate the Long-term Safety of HS-10380 in Patients With Schizophrenia
Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.
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
Conditions
Interventions
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