Study to Assess the Safety, Tolerability, and Treatment Response of GXV813 in Hospitalized Adults With Schizophrenia

Inclusion Criteria12

• Participant is aged 18 to 65 years, inclusive, at screening
• Participant is capable of providing informed consent
• Participant has a primary diagnosis of schizophrenia, established by a comprehensive psychiatric evaluation based on the DSM-5 (American Psychiatric Association 2013) criteria and confirmed by Structured Clinical Interview for DSM-5 Clinical Trials version (SCID-5-CT)
• Participant is willing and able to be confined to an inpatient setting for the study duration (except for the follow-up period), follow instructions, and comply with the protocol requirements
• Participant is experiencing an acute exacerbation or relapse of psychotic symptoms, with onset less than 2 months before screening
• The participant requires hospitalization for this acute exacerbation or relapse of symptoms
• If already an inpatient at screening, has been hospitalized for less than 2 weeks for the current exacerbation at the time of screening
• Positive and Negative Syndrome Scale total score between 80 and 120, inclusive, at screening a. Score of ≥ 4 (moderate or greater) for ≥ 2 of the following Positive Scale (P) items:
• i. Item 1 (P1; delusions)
• ii. Item 2 (P2; conceptual disorganization)
• iii. Item 3 (P3; hallucinatory behavior)
• iv. Item 6 (P6; suspiciousness/persecution)