A Study to Evaluate the Dose Levels, Safety, and Drug Levels of Single KarXT Intramuscular Injection in Participants With Schizophrenia

Launched by BRISTOL-MYERS SQUIBB · Jul 2, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called KarXT, given as a single injection into the muscle, for people living with schizophrenia. The main goal is to find out the right dose to use, check if the treatment is safe, and understand how the medicine behaves in the body. This study is in its early phase, which means it’s mainly focused on safety and dosage rather than effectiveness.

People who may join the study need to have a confirmed diagnosis of schizophrenia, with symptoms that are not too severe. They should be between 18 and 74 years old and have a body weight within a healthy range. Participants must be willing to stop taking other antipsychotic medications during the trial and be able to follow the study rules. Certain people, such as those with recent diagnoses, other mental health conditions, substance abuse issues, or who are pregnant or breastfeeding, will not be eligible. If you join, you can expect careful monitoring to ensure your safety, and you will receive one injection of KarXT to see how your body responds. This study is not yet open for participants but may offer a new option for managing schizophrenia in the future.

Gender

ALL

Eligibility criteria

• • 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.