A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Brexpiprazole for Extended-Release Injection in Subjects With Schizophrenia

Sponsor
Bostal Drug Delivery Co., Ltd
Study ID
NCT07742280
Phase
PHASE2/PHASE3
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Brexpiprazole for ER injection, 45 mg — DRUG
    Single-dose, Subcutaneous
  • Brexpiprazole for ER injection, 100 mg — DRUG
    Single-dose, Subcutaneous

Study Details

This study is to evaluate the pharmacokinetics (PK), safety and tolerability of Brexpiprazole, administered subcutaneously, in subjects with schizophrenia.

Key Dates

First listed
Aug 3, 2026
Start date
Aug 31, 2026
Status verified
Jul 2026
Primary completion
Aug 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
16 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Brexpiprazole for ER injection, 45 mg
  • Experimental: Brexpiprazole for ER injection, 100 mg

Primary Outcome Measure

Cmax [ Time Frame: Pre-dose to 190 days post-dose ]

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