RecruitingPhase 1NCT07484204

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


Sponsor

Anxo Pharmaceutical Co., Ltd.

Enrollment

48 participants

Start Date

Sep 14, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called AX251 LAI 135 mg, a drug called AX251 LAI 180 mg, and others for people with schizophrenia. The study is currently recruiting participants at 4 locations. People eligible for this study include aged 18 Years to 65 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAX251 LAI 45 mg

Cariprazine 45 mg

DRUGAX251 LAI 90 mg

Cariprazine 90 mg

DRUGAX251 LAI 135 mg

Cariprazine 135 mg

DRUGAX251 LAI 180 mg

Cariprazine 180 mg


Locations(4)

DHS Multispeciality Hospital

Ahmedabad, India

Health Hospital

Ahmedabad, India

Divine Multispeciality Hospital

Gandhinagar, India

Ratandeep Multispeciality Hospital

Nagar, India

View Full Details on ClinicalTrials.gov

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NCT07484204


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