NCT07759869Not yet recruitingPhase 3
A Study to Evaluate the Long-term Safety of HS-10380 in Patients With Schizophrenia
A Multicenter, Open-label, Phase 3 Study to Evaluate the Long-term Safety of HS-10380 in Chinese Adult Patients With Schizophrenia
Source: ClinicalTrials.gov · Last updated 12 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 500 (estimated)
- First submitted
- 7 Aug 2026
- Start date
- 9 Sept 2026
- Primary completion date
- 31 Jul 2028
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
- Diseases
- Schizophrenia
- NCT number
- NCT07759869
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 500
- From 9 Sept 2026 to the primary completion date, 31 Jul 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of drug abuse within 1 year prior to screening.
- History of alcohol abuse within 6 months prior to screening.
Other illness
- 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.
Other
- 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 .
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking University Sixth Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.