A Trial of 15 and 30 mg Doses of CVL-231 (Emraclidine) in Participants With Schizophrenia

Inclusion Criteria: * Primary diagnosis of schizophrenia per DSM-5, as confirmed by the MINI for Psychotic Disorders. * CGI-S ≥4 (moderately to severely ill) at the time of signing the ICF and Baseline. * PANSS Total Score between 85 and 120, inclusive, at the time of signing the ICF and at Baseline. * Experiencing an acute exacerbation or relapse of psychotic symptoms, with onset less than 60 days prior to signing the ICF. * Willing to discontinue all prohibited medications to meet protocol-required washouts prior to and during the trial period. * Body mass index of 18.0 to 40.0 kg/m2 and a total body weight ≥50 kg (110 lbs). * Ability, in the opinion of the investigator, to understand the nature of the trial, participate in trial visits, and comply with protocol requirements. Exclusion Criteria: * Current DSM-5 diagnosis other than schizophrenia (note: anxiety symptoms secondary to schizophrenia are allowed); Acute depressive symptoms within 30 days prior to signing the ICF that require treatment with an antidepressant are exclusory. Acute manic symptoms within 30 days prior to signing the ICF that require treatment with a mood stabilizer are exclusory. * Any of the following: * Schizophrenia considered resistant/refractory to antipsychotic treatment by history (failure to respond to 2 or more courses of adequate pharmacological treatment defined as an adequate dose per label and a treatment duration of at least 4 weeks) * History of response to clozapine treatment …