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.