A Study to Evaluate the Long-term Safety of HS-10380 in Patients 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.

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 .