A Study to Evaluate Iloperidone Long-acting Injection (LAI) for the Treatment of Schizophrenia

An Open-label, Adaptive, Repeat-dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Iloperidone Long-acting Injection (LAI) in Patients With Schizophrenia

This is a multicenter, open-label, adaptive, repeat-dose study to evaluate the safety, tolerability, and pharmacokinetics of iloperidone long-acting injection (LAI) in patients with schizophrenia.

Inclusion Criteria:

• Willing and able to provide written informed consent.
• Male or female patients 18 to 65 years of age (inclusive).
• Clinical diagnosis of schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorder (DSM-5) for at least 1 year.
• Symptomatically stable within the past two months.

Exclusion Criteria:

• Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer.
• Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs.
• Pregnant or nursing (lactating) women.
• A positive test for drugs of abuse.