Study of SPG302 in Adults With Schizophrenia

A Randomized, Placebo-controlled, Double-blind Phase 2 Study to Assess the Efficacy, Safety, Tolerability, and Pharmacodynamics of SPG302 in Adult Participants Diagnosed With Schizophrenia

This Phase 2 study described herein will evaluate the safety, efficacy, tolerability, and pharmacodynamics of SPG302 in adults with a primary diagnosis of schizophrenia.

This Phase 2 study will evaluate the safety, efficacy, tolerability, and pharmacodynamics of SPG302 in adults with a primary diagnosis of schizophrenia. This is a randomized, placebo-controlled study of SPG302 administered once daily for six weeks.

This study will entail weekly visits to the study site for screening, study procedures, and receipt of investigational medication for use at home.

Inclusion Criteria:

• Age 18-65
• Primary diagnosis of schizophrenia
• Clinical laboratory values within normal range or < 1.5 times ULN
• Currently prescribed only one antipsychotic medication, with stable dose for at least 4 weeks
• Able and willing to provide written informed consent

Exclusion Criteria:

• Any physical or psychological condition that prohibits study completion
• Known cardiac disease
• Active or history of malignancy in the past 5 years
• History of clinically significant CNS event or diagnosis in the past 5 years.
• Receipt of investigational products within 30 days
• Blood donation within 30 days