Safety, Tolerability, and Pharmacokinetics of Lumateperone Long-Acting Injectable Formulations in Patients With Schizophrenia or Schizoaffective Disorder

Main Inclusion Criteria:

• Male or female patients between 18 and 55 years of age, inclusive;

• Clinical diagnosis of schizophrenia or schizoaffective disorder according toDiagnostic and Statistical Manual of Mental Disorders (DSM-5);

• Clinically stable and free from acute exacerbation of psychosis for at least 3months prior to Screening;

• Clinical Global Impression - Severity (CGI-S) score ≤ 3 at Screening and prior todosing on Day 1;

• Body mass index (BMI) between 18.0 and 38.0 kg/m2, inclusive at Screening, and aminimum body weight of 50 kg at Screening.

Main Exclusion Criteria:

• History of psychiatric condition other than schizophrenia that, in theInvestigator's opinion, may be detrimental to participation in the study;

• Any suicidal ideation or wish to be dead within the past 6 months of Screening, anysuicide attempt within the past 2 years prior to Screening, or any current concernfor the patient's safety based on the Columbia-Suicide Severity Rating Scale (C-SSRS) (excluding self-injurious, non-suicidal behavior), and/or Investigatorassessment that the patient is a safety risk to him/herself or others;

• Clinically significant abnormality within 2 years of Screening that in theInvestigator's opinion may place the patient at risk or interfere with study outcomevariables;

• Has a QT interval corrected for heart rate using Fridericia formula > 450 msec inmales or > 470 msec in females, or evidence of clinically significant bundle branchblocks on ECG at Screening.