HS-10380: Oral;QD;W1:dose titration; W1-2:dose adjust to optimal level;Week 3-52:stable dose.
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria:
* 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 Criteria:
* 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.
* 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.
* Female patients who are pregnant, in puerperium, or lactating at screening or baseline.
* History of drug abuse within 1 year prior to screening.
* History of alcohol abuse within 6 months prior to screening.
* Abnormal physical examination findings、vital signs or 12-lead electrocardiogram (ECG) at screening .
Primary outcome measure(s)
Incidence and severity of adverse events (AE) — From first dose to end of study (Up to approximately 54 weeks ) TEAEs are defined as events with an onset date on or after the first dose of HS-10380. An Adverse Event is any symptom, physical sign, syndrome, or disease that either emerges during the study or, if present at baseline, worsens during the study, regardless of the suspected cause of the event.
Incidence and severity of serious adverse events (SAE) — From first dose to end of study (Up to approximately 52 weeks) An SAE is any untoward medical occurrence, in the view of either the investigator or sponsor, that results in death; is life-threatening; results in inpatient hospitalization or prolongation of existing hospitalization ; results in persistent or significant disability/incapacity, and/or; is a congenital anomaly/birth defect.
Incidence of Treatment-Emergent Adverse Events (TEAE) Leading to Study Drug Discontinuation — From first dose to end of study (Up to approximately 54 weeks ) TEAEs are defined as events with an onset date on or after the first dose of HS-10380. An Adverse Event is any symptom, physical sign, syndrome, or disease that either emerges during the study or, if present at baseline, worsens during the study, regardless of the suspected cause of the event.
Trial sites (1)
Facility
City
Region
Status
Peking University Sixth Hospital
Beijing
Beijing Municipality
More Jiangsu Hansoh Pharmaceutical Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.