Novartis Pharmaceuticals
This study is designed to assess the safety and tolerability of the effects of XEP527, with particular emphasis on disease status and its compatibility with the standard of care in patients with stable schizophrenia.
This is a randomized, participant and investigator blinded, placebo-controlled, multicenter study in stable schizophrenic patients divided into three dosing cohorts. This study will include a screening period up to 28 days, an inpatient treatment period of 28 days of the study drug (XEP527 or placebo) and a follow-up period of 28 days
Key Inclusion Criteria: * Signed informed consent must be obtained prior to participation in the study * Participants 18 to 65 years of age, inclusive at screening * Participant agrees to be hospitalized starting at Day -1 and for at least 28 days after randomization * Participant has a primary diagnosis of schizophrenia established by a comprehensive psychiatric evaluation based on the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria and confirmed by Mini International Neuropsychiatric Interview for Schizophrenia and Psychotic Disorder Studies (MINI), versi…
Participants will receive XEP527
Placebo
Arctuva estimate
Actual pay is set by the research site.
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