The Purpose of This Study is to Determine the Safety, Tolerability, and Pharmacokinetics o
Study to evaluate the safety and tolerability of single ascending doses of brexpiprazole long-acting injection in healthy subjects/patients with schizophrenia.
| Condition(s) | Schizophrenia Disorders |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| Summary | Study to evaluate the safety and tolerability of single ascending doses of brexpiprazole long-acting injection in healthy subjects/patients with schizophrenia. |
| Who can participate | 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, |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | Sichuan Kelun Pharmaceutical Co., Ltd |
| Locations | Beijing, Beijing Municipality, China |
| Start date | 2024-04-10 |
| NCT ID | NCT06674694 |
| Official listing | https://clinicaltrials.gov/study/NCT06674694 |