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.
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.
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.
Single group
HS-10380
DrugOral;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.
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.
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.
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.
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.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
