drugset / 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.

NCT06674694

Phase 1 Recruiting 56 enrolled Sichuan Kelun Pharmaceutical Co.,Ltd.
RandomizedParallel-groupOpen-labelTreatment

Summary

Study to evaluate the safety and tolerability of single ascending doses of brexpiprazole long-acting injection in healthy subjects/patients with schizophrenia.

Timeline

Start
2024-04-10
Primary completion
2026-06-30
Completion
2026-10-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Brexpiprazole Small molecule 20 mg
Subject Brexpiprazole Small molecule 40 mg
Subject Brexpiprazole Small molecule 80 mg
Subject Brexpiprazole Small molecule 160 mg
Subject Brexpiprazole Small molecule 240 mg
Subject Brexpiprazole Small molecule 320 mg

Indications