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.

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.

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (estimated)
• Sponsor: Sichuan Kelun Pharmaceutical Research Institute Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• Schizophrenia Disorders

Interventions

Type	Name	Description
DRUG	Brexpiprazole long-acting injection	A single injection was administered.

Timeline

• Start date: 2024-04-10
• Primary completion: 2026-06-30
• Completion: 2026-10-30
• First posted: 2024-11-05
• Last updated: 2025-11-17

Locations

1 site across 1 country: China