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

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.