Efficacy, Safety, Tolerability, and Pharmacokinetics of NBI-1117568 in Adults With Schizophrenia

Key Inclusion Criteria:

• Completed informed consent.

• Subject has a primary diagnosis of schizophrenia.

• The subject is experiencing an acute exacerbation or relapse of symptoms andcurrently requires hospitalization.

• Subjects taking prohibited medications, including antipsychotics, must discontinuebefore study participation

• Subject is willing and able to remain in an inpatient setting for the studyduration, follow instructions, and comply with the protocol requirements.

Key Exclusion Criteria:

• An unstable medical condition, chronic disease, or malignancy.

• Considered by the investigator to be at imminent risk of suicide or injury to selfor others.

• Diagnosis of moderate or severe substance use disorder (with the exception ofnicotine or caffeine dependence) within 6 months prior to screening.

• Positive alcohol test or drug screen for disallowed substances.

• Have a history of poor or suspected poor compliance in clinical research studiesand/or in the investigator's opinion, the subject is not capable of adhering to theprotocol requirements.