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