A Phase 3 interventional study of HS-10380 in SCHIZOPHRENIA 1 (Disorder), sponsored by Jiangsu Hansoh Pharmaceutical Co., Ltd.. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-08-12.
Sponsored by Jiangsu Hansoh Pharmaceutical Co., Ltd. · Phase 3, Interventional, and Treatment
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.
The study will comprise 3 periods : a Screening Period, an Open-Label Treatment Period during which participants will be treated for 52 weeks and a 14-day Follow-up Period before an End of Study (EOS) Visit. The total study duration for each participant on this study is 57 weeks.
Exclusion Criteria:
Drug: HS-10380
Oral;QD;W1:dose titration; W1-2:dose adjust to optimal level;Week 3-52:stable dose.
Incidence and severity of adverse events (AE)
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.
Time frame: From first dose to end of study (Up to approximately 54 weeks )
Incidence and severity of serious adverse events (SAE)
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.
Time frame: From first dose to end of study (Up to approximately 52 weeks)
Incidence of Treatment-Emergent Adverse Events (TEAE) Leading to Study Drug Discontinuation
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.
Time frame: From first dose to end of study (Up to approximately 54 weeks )
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score
The PANSS rating form contains 7 positive symptom scales, 7 negative system scales, and 16 general psychopathology symptom scales. Participants are rated from 1 to 7 on each symptom scale. The positive symptoms in schizophrenia are the excess or distortion of normal function and the negative symptoms are the diminution or loss of normal functions . PANSS total score is the sum of all 30 items with a minimum score of 30 and a maximum score of 210. Higher scores indicate more severe symptoms.
Time frame: Open-label extension baseline, week 52
Change from Baseline in Clinical Global Impression-Severity (CGI-S) Score
The CGI-S modified asked the clinician 1 question: "Considering your total clinical experience, how mentally ill is the participant at this time?" The clinician's answer rated on the following 7-point scale: 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; 7 = among the most extremely ill participants.
Time frame: Open-label extension baseline, week 52
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Jiangsu Hansoh Pharmaceutical Co., Ltd.