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NOT YET RECRUITING
NCT07484204
PHASE1

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

Sponsor: Anxo Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

48

Start Date

2026-07

Completion Date

2028-07

Last Updated

2026-03-20

Healthy Volunteers

No

Conditions

Interventions

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

Locations (1)

Ratandeep Multispeciality Hospital

Nagar, India