Long-term Safety Study of HS-10380 in People With Schizophrenia
Tests how safe HS-10380 is over time in Chinese adults with schizophrenia.
Plain-language title generated from the registry record
Registry title: A Study to Evaluate the Long-term Safety of HS-10380 in Patients With Schizophrenia
Key facts
- Where
- Beijing, ChinaSee the site
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT07759869, who can take part
Where in China
- Peking University Sixth HospitalBeijing, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
- Trial code
- NCT07759869
- Record updated
- 12 August 2026
- Original description
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.Read full original descriptionShow less
A Multicenter, Open-label, Phase 3 Study to Evaluate the Long-term Safety of HS-10380 in Chinese Adult Patients With Schizophrenia
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.
Inclusion: Participant is aged 18-65 years, inclusive, at screening; Body mass index must be ≥18.0 and ≤40.0 kg/m² at screening; Participant has a primary diagnosis of schizophrenia established by a comprehensive psychiatric evaluation based on the DSM-5 criteria; Willing and able to give informed consent/assent as per local requirements; Participants are willing and able to discontinue all antipsychotic medications prior to the baseline visit, as determined by the investigator.
Exclusion: History of drug abuse within 1 year prior to screening; History of alcohol abuse within 6 months prior to screening; History or presence of clinically significant disease or any other condition that, in the opinion of the investigator, would jeopardize the safety of the subject or the validity of the study results; Any surgical condition or medical condition that may significantly affect drug absorption, distribution, metabolism, and excretion, or that may pose a risk to trial participants, such as history of gastrointestinal surgery (gastrectomy, gastroenterostomy, bowel resection, etc.), urinary tract obstruction, or dysuria; History of severe allergic reactions; Participant has a current DSM-5 diagnosis or presence of symptoms consistent with a DSM-5 diagnosis other than schizophrenia; Judged by the investigator as having treatment-resistant schizophrenia; Patients with risk of violent or destructive behavior, or suicidal risk; Female patients who are pregnant, in puerperium, or lactating at screening or baseline; Abnormal physical examination findings、vital signs or 12-lead electrocardiogram (ECG) at screening .