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Not yet recruiting NCT07484204

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

Phase I Interventional Schizophrenia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: AX251 LAI 45 mg, AX251 LAI 90 mg, AX251 LAI 135 mg, AX251 LAI 180 mg.
Who it may be relevant to
Registry conditions: Schizophrenia. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
India
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

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

Primary outcome measures

  • Pharmacokinetic Parameter [Time frame: Day 1 pre-dose and 1, 2, 3, 4, 8, 12, and 24 hours post-dose. Days 3, 5, 7, 14, 21, 28, 42, 56, and 70]
Secondary outcome measures (1)
  • Safety: Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) [Time frame: Baseline to Day 70]

Eligibility criteria

Inclusion criteria

  • Male or female subjects aged 18 to 65 years (inclusive).
  • clinical diagnosis of schizophrenia per the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) (or later) criteria, at screening.
  • Body Mass Index (BMI) 18.5-35.0 kg/m² at screening.
  • Clinical Global Impression-Severity (CGI-S) score ≤4 at screening.
  • Positive and Negative Syndrome Scale (PANSS) total score ≤75 at screening.
  • Clinically stable schizophrenia on current antipsychotic medication other than cariprazine for at least 3 months prior to screening.
  • Subjects must not be taking more than two antipsychotic medications.
  • Able to remain at the study site for 7 days following AX251 LAI injection.
  • Judged by the investigator to be physically and mentally able to participate in the study based on clinical evaluation, physical examination, electrocardiogram (ECG), and laboratory assessments.
  • Willing and able to comply with study procedures.
  • Agrees to use protocol-defined contraception during the study.
  • Previous tolerability to oral cariprazine (1.5-6 mg) or willingness to undergo a short oral tolerability test (2-7 days) followed by washout before study drug administration.

Exclusion criteria

  • Diagnosis of psychiatric disorders other than schizophrenia according to DSM-5-TR (e.g., schizoaffective disorder, major depressive disorder, bipolar disorder, generalized anxiety disorder, obsessive-compulsive disorder, post-traumatic stress disorder, dementia, mild neurocognitive disorder, or personality disorders), except caffeine- or tobacco-related disorders.
  • Substance use disorder (including alcohol or benzodiazepines) within 180 days prior to screening, excluding caffeine and tobacco.
  • History of neuroleptic malignant syndrome, seizure disorder, or clinically significant tardive dyskinesia, akathisia, or extrapyramidal symptoms.
  • Clinically significant cardiovascular, hematologic, metabolic, hepatic, renal, immunologic, or neurological disease that may interfere with study participation.
  • Severe hepatic impairment (Child-Pugh Class C) at screening.
  • Uncontrolled hypertension.
  • Clinically significant electrocardiogram abnormalities at screening.
  • Severe renal impairment (estimated glomerular filtration rate <30 mL/min).
  • History of syncope or significant orthostatic hypotension at screening.
  • Failure to complete required washout period (≥5 half-lives) for prohibited medications before administration of AX251 LAI.
  • Current treatment with other antipsychotic long-acting injectable (LAI) therapies.
  • Electroconvulsive therapy within 60 days prior to screening.
  • Acute psychosis posing imminent risk to self or others.
  • Acute relapse of schizophrenia at screening.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

India · 4 centers
  • DHS Multispeciality Hospital — Ahmedabad
  • Health Hospital — Ahmedabad
  • Divine Multispeciality Hospital — Gandhinagar
  • Ratandeep Multispeciality Hospital — Nagar

Identifiers

NCT: NCT07484204 · AX251-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗