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

NCT07484204 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2026-03-20

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Anxo Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-31
Primary Completion
2028-07-31
Completion
2028-07-31
FDA Drug
Yes

Countries

  • India

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07484204 on ClinicalTrials.gov