Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-26 @ 3:16 PM
NCT ID:
NCT07484204
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT07484204
Study Brief:
Protocol Section:
NCT07484204