Clinical Research Directory

Inclusion Criteria: * BMI \> 17.5 and \< 38.0 kg/m2 and a total body weight \> 50.0 kg (110 lbs) * Primary diagnosis of schizophrenia per the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5-TR) * Experiencing an acute exacerbation or relapse of symptoms, with onset less than 2 months prior to screening for the study * PANSS total score ≥ 80 at the time of screening for the study * Not currently on antipsychotic medication, or is willing to discontinue all prohibited psychotropic medications prior to and during the trial period * Sexually active adults must be willing to use an acceptable contraceptive method throughout the study Exclusion Criteria: * Evidence of organ dysfunction or any clinically significant abnormal finding at physical examination * History of treatment resistance (e.g., failure to respond to ≥ 2 adequate antipsychotic trials) or failure to respond to use of clozapine * Current DSM-5-TR diagnosis other than schizophrenia * Pregnant or lactating female * Substance use disorder within 1 year prior to screening or recreational use of drugs within 3 months prior to screening * Moderate to severe alcohol use disorder as per DSM-5-TR within the past year or excessive use of alcohol within 12 months prior to screening * Positive testing for human immunodeficiency virus (HIV)-1 and -2 antibody, hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibody at screening