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NCT07061288PHASE1Recruiting

A Study to Evaluate the Safety, Tolerability, and PK of an Injectable Form of KarXT

Bristol-Myers Squibb

Start Date

9/3/2025

Completion Date

10/15/2027

Summary

A study to evaluate the safety, tolerability, and PK of an injectable form of KarXT in participants with schizophrenia

Eligibility Criteria

Age Range: 18 years to 55 years

Inclusion Criteria * Participants must have a primary diagnosis of schizophrenia, as confirmed by psychiatric evaluation based on Diagnostic and Statistical Manual of Mental Disorders (5th Edition, Text Revision) (DSM-5-TR) criteria and Mini International Neuropsychiatric Interview (MINI) (version 7.0.2). * Participants must have a Positive and Negative Syndrome Scale (PANSS) total score ≤ 80 and a Clinical Global Impression - Severity (CGI-S) score ≤ 4 at both screening and baseline. * Participants must have a body mass index (BMI) between 18 and 40 kg/m². * Participants should be willing and able, as determined by the investigator, to discontinue all antipsychotic medications prior to the baseline visit and must be able to comply with all protocol requirements. Exclusion Criteria * Participants must not have newly diagnosed schizophrenia or a first treated episode of schizophrenia. * Participants must not have any other DSM-5-TR disorder diagnosed within the past 12 months, such as major depressive disorder or bipolar disorder. * Participants must not have a history of alcohol or drug use disorder within the past 12 months or those with clinically significant disease or disorder that would jeopardize their safety or affect the validity of study results. * Participants must not be at risk for suicidal behavior. * Female participants must not be pregnant or breastfeeding. * Other protocol-defined Inclusion/Exclusion criteria apply.

Interventions

DRUG

KarXT

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Conditions

Schizophrenia

Locations

Collaborative Neuroscience Research, LLC

Los Alamitos, California 90720-3118

United States

Research Centers of America ( Hollywood )

Hollywood, Florida 33024

United States

Innovative Clinical Research, Inc.

Miami Lakes, Florida 33016

United States

Atlanta Center for Medical Research

Atlanta, Georgia 30331

United States

CenExel iResearch, LLC

Decatur, Georgia 30030

United States

Uptown Research Institute

Chicago, Illinois 60640

United States

Hassman Research Institute Marlton Site

Marlton, New Jersey 08053

United States

Community Clinical Research

Austin, Texas 78754

United States