A Phase I Clinical Study of the Safety, Tolerability, and Pharmacokinetics of a Single Dose of Brexpiprazole Long-acting Injection in Healthy Subjects/Patients With Schizophrenia.
Study to evaluate the safety and tolerability of single ascending doses of brexpiprazole long-acting injection in healthy subjects/patients with schizophrenia.
⁃ Healthy Volunteers:
• Male and female subjects aged 18 to 65 years (including) at the time of signing the informed consent (the number of single sex in each group is not less than 1/4);
• Body mass index (BMI) in the range of 19.0-26.0 (including the critical value), and female weight ≥ 45 kg, male weight ≥ 50 kg;
• Subjects of childbearing potential (including partners) have no pregnancy plan or sperm donation and egg donation plan since signing the informed consent form to within 1 year after the last dose of the investigational drug, and voluntarily take effective contraceptive measures;
• Sign informed consent before the trial, and fully understand the trial content, process and possible adverse reactions;
• Subjects can communicate well with the investigator, and understand and comply with the requirements of this study.
⁃ Patients with schizophrenia:
• Male and female subjects aged 18 to 65 years (including) at the time of signing the informed consent (the number of single sex in each group is not less than 1/4);
• Patients diagnosed with schizophrenia according to ICD-10, and the positive and negative symptom scale (PANSS) score ≤ 70 points, and the investigator judged stable disease within 4 weeks before screening;
• Body mass index (BMI) ≥ 18.5 kg/m2 and \< 35.0 kg/m2, and female weight ≥ 45 kg, male weight ≥ 50 kg;
• Subjects need to complete the tolerance test according to the protocol requirements;
• Subjects of childbearing potential (including partners) have no pregnancy plan or sperm donation and egg donation plan since signing the informed consent form to within 1 year after the last dose of the investigational drug, and voluntarily take effective contraceptive measures;
• Subjects and their guardians signed informed consent;
• Subjects and their guardians agree to comply with the protocol and cooperate with the investigator to complete the trial.