NCT07484204

Evaluate Pharmacokinetics, Safety, and Tolerability of AX251 LAI in Patients With Schizophrenia

An Open-label, Multicenter Study to Determine the Pharmacokinetics, Safety, and Tolerability of AX251 Long-Acting Injectable (LAI) Administered as a Single Dose in Patients With Schizophrenia

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Anxo Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the pharmacokinetics (PK), safety, and tolerability of AX251 long-acting injectable (LAI) administered as a single dose in patients with schizophrenia. The study will include sequential dose-escalation cohorts to evaluate different dose levels of AX251 LAI.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	AX251 LAI 45 mg	Cariprazine 45 mg
DRUG	AX251 LAI 90 mg	Cariprazine 90 mg
DRUG	AX251 LAI 135 mg	Cariprazine 135 mg
DRUG	AX251 LAI 180 mg	Cariprazine 180 mg

Timeline

• Start date: 2026-07-01
• Primary completion: 2028-07-01
• Completion: 2028-07-01
• First posted: 2026-03-20
• Last updated: 2026-03-20

Locations

1 site across 1 country: India

Regulatory

• FDA-regulated drug study