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
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