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

An Open-label, Phase 1, Single Ascending Dose-Finding Study to Characterize the Safety, Tolerability, and Pharmacokinetics of a Long Acting Injectable KarXT Formulation in Participants With Schizophrenia

This will test whether a single intramuscular injection of KarXT is safe and what drug levels it produces in adults with schizophrenia who can stop other antipsychotic medications.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: Bristol-Myers Squibb (Industry-sponsored)
• Locations: 8 sites (Los Alamitos, California and 7 other locations)
• Trial ID: NCT07061288 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults with DSM-5-TR diagnosed schizophrenia who meet stability criteria (PANSS total ≤ 80, CGI-S ≤ 4), have BMI 18–40 kg/m², and are willing/able to discontinue other antipsychotics are ideal candidates.

Not a fit: Patients with newly diagnosed or first-episode schizophrenia, recent other primary DSM-5-TR disorders, or those who cannot stop existing antipsychotic treatment are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, a long-acting injectable form of KarXT could offer an alternative dosing option that may improve adherence and reduce relapse risk for some patients.

How similar studies have performed: Oral KarXT formulations have shown positive efficacy and safety signals in prior trials, but a single long-acting intramuscular KarXT injection is a novel formulation that has not been widely tested.

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.

Where this trial is running

Los Alamitos, California and 7 other locations

• 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)
• Hassman Research Institute Marlton Site — Marlton, New Jersey, United States (Recruiting)
• Community Clinical Research — Austin, Texas, United States (Recruiting)

Study contacts

• Study coordinator: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

Conditions Schizophrenia; KarXT; Long-acting injectable; Cobenfy