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 to
Diagnostic and Statistical Manual of Mental Disorders (DSM-5);

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

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

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

Main Exclusion Criteria:

- History of psychiatric condition other than schizophrenia that, in the
Investigator'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, any
suicide attempt within the past 2 years prior to Screening, or any current concern
for the patient's safety based on the Columbia-Suicide Severity Rating Scale
(C-SSRS) (excluding self-injurious, non-suicidal behavior), and/or Investigator
assessment that the patient is a safety risk to him/herself or others;

- Clinically significant abnormality within 2 years of Screening that in the
Investigator's opinion may place the patient at risk or interfere with study outcome
variables;

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