Single KarXT intramuscular injection to test dosing and safety in people with schizophrenia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1, interventional trial gives a single intramuscular injection of KarXT at one of several dose levels to adults with diagnosed schizophrenia. Participants who meet stability criteria stop other antipsychotic medications and receive close clinical monitoring and blood draws to measure drug levels over time. The main goals are to characterize safety, tolerability, and pharmacokinetics after one dose. The trial is conducted at a small number of U.S. clinical sites with scheduled follow-up visits to capture adverse events and laboratory results.

Why it matters

Who can join: the full rules

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.

Where it's running

• Collaborative Neuroscience Research, LLC
  Los Alamitos, California, United States Recruiting
• Research Centers of America ( Hollywood )
  Hollywood, Florida, United States Recruiting
• Innovative Clinical Research, Inc.
  Miami Lakes, Florida, United States Recruiting
• Atlanta Center for Medical Research
  Atlanta, Georgia, United States Recruiting
• CenExel iResearch, LLC
  Decatur, Georgia, United States Recruiting
• Uptown Research Institute
  Chicago, Illinois, United States Recruiting

Study contacts

• Study coordinator: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
• Email: Clinical.Trials@bms.com
• Phone: 855-907-3286

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.