The Purpose of This Study is to Determine the Safety, Tolerability, and Pharmacokinetics of Brexpiprazole Long-acting Injection Following a Single Administration in Healthy Subjects/Patients With Schizophrenia.
Trial Parameters
Brief Summary
Study to evaluate the safety and tolerability of single ascending doses of brexpiprazole long-acting injection in healthy subjects/patients with schizophrenia.
Eligibility Criteria
Inclusion Criteria: Healthy Volunteers: 1. 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); 2. 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; 3. 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; 4. Sign informed consent before the trial, and fully understand the trial content, process and possible adverse reactions; 5. Subjects can communicate well with the investigator, and understand and comply with the requirements of this study. Patients with schizophrenia: 1. Male and female subjects aged 18 to 65 years (including) at the time of signing the informed consent (the