Actively Recruiting
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.
Led by Sichuan Kelun Pharmaceutical Research Institute Co., Ltd. · Updated on 2025-11-17
56
Participants Needed
1
Research Sites
133 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Study to evaluate the safety and tolerability of single ascending doses of brexpiprazole long-acting injection in healthy subjects/patients with schizophrenia.
CONDITIONS
Official Title
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.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female subjects aged 18 to 65 years at the time of signing informed consent
- For healthy volunteers: BMI between 19.0 and 26.0, female weight at least 45 kg, male weight at least 50 kg
- For patients with schizophrenia: diagnosed according to ICD-10 with PANSS score 70 or less and stable disease within 4 weeks before screening
- For patients with schizophrenia: BMI between 18.5 and 35.0 kg/m2, female weight at least 45 kg, male weight at least 50 kg
- Subjects of childbearing potential and their partners must have no pregnancy or sperm/egg donation plans from consent until 1 year after last dose, and agree to use effective contraception
- Subjects and their guardians must sign informed consent and agree to comply with the study protocol
- Subjects must be able to communicate well and understand the study requirements
You will not qualify if you...
- History of significant cardiovascular, endocrine, urinary, nervous, hematologic, immunologic, or metabolic disorders
- Abnormal clinically significant physical exam, vital signs, ECG, lab tests, chest X-ray or CT, ultrasound, or injection site findings
- Prior use of brexpiprazole preparation within 28 days before oral tolerance test
- Participation in other clinical trials with investigational drugs or devices within 28 days before dosing
- Use of drugs interacting with brexpiprazole within 30 days before administration
- Use of any drugs, including prescription, over-the-counter, or traditional medicines, within 14 days before administration
- Consumption of foods or beverages affecting drug metabolism within 48 hours before dosing
- Excessive alcohol or caffeine consumption before administration
- Smoking more than 3 cigarettes per day within 3 months before dosing
- History of drug dependence or abuse, positive drug or alcohol tests
- Blood donation or transfusion within 1 month before administration
- Surgery within 1 month before administration or planned surgery during the study
- Allergies to study drug components or excipients
- Pregnancy or lactation
- Unprotected sex within 2 weeks before dosing
- For patients with schizophrenia: other psychiatric diseases, unstable cardiovascular or cerebrovascular diseases, poorly controlled diabetes, abnormal hematopoiesis or major organ function, seizure disorders, severe suicidal tendencies, Parkinson's disease, malignant syndrome, or dementia-related psychosis
- Use of electroconvulsive therapy within 14 days prior to screening
- Positive infectious disease markers (HBsAg, HCV-Ab, HIV, syphilis)
- Investigator judgment of unsuitability for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Beijing Anding Hospital Capital Medical University
Beijing, Beijing Municipality, China, 100000
Actively Recruiting
Research Team
W
Wei Qi
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
6
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