clinical trial · NCT06674694
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.
Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.·phase1·recruiting·n = 56
Schizophrenia DisordersBrexpiprazole long-acting injection
brief summary
Study to evaluate the safety and tolerability of single ascending doses of brexpiprazole long-acting injection in healthy subjects/patients with schizophrenia.
started
Apr 10, 2024
primary completion
Jun 30, 2026
completion
Oct 30, 2026
last updated
Nov 17, 2025
detailed description
The 20mg group and 40mg group of the study will evaluate the safety and tolerability, PK of single ascending doses of of brexpiprazole long-acting injection in 24 healthy subjects,other groups of the study will evaluate the safety and tolerability, PK of single ascending doses of of brexpiprazole long-acting injection in 32 patients with schizophrenia.
official title
A Phase I Clinical Study of the Safety, Tolerability, and Pharmacokinetics of a Single Dose of Brexpiprazole Long-acting Injection in Healthy Subjects/Patients With Schizophrenia.
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