A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Brexpiprazole for Extended-Release Injection in Subjects With Schizophrenia
NCT07742280 · Status: NOT_YET_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 16
Last updated 2026-08-03
Summary
This study is to evaluate the pharmacokinetics (PK), safety and tolerability of Brexpiprazole, administered subcutaneously, in subjects with schizophrenia.
Conditions
Interventions
- DRUG
-
Brexpiprazole for ER injection, 45 mg
Single-dose, Subcutaneous
- DRUG
-
Brexpiprazole for ER injection, 100 mg
Single-dose, Subcutaneous
Sponsors & Collaborators
-
Bostal Drug Delivery Co., Ltd
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-08-31
- Primary Completion
- 2027-08-31
- Completion
- 2027-12-31
- FDA Drug
- Yes
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