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

Recruiting now · Phase 1

Conditions studied: Schizophrenia

In brief

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

Key facts

Study ID

NCT07061288

Run by

Bristol-Myers Squibb

People needed

116

Starts

2025-09-03

Expected to finish

2027-10-15

Last updated by the study team

2026-06-12

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 is running

• Collaborative Neuroscience Research, LLC — Los Alamitos, California, United States (enrolling)
• Research Centers of America ( Hollywood ) — Hollywood, Florida, United States (enrolling)
• Innovative Clinical Research, Inc. — Miami Lakes, Florida, United States (enrolling)
• Atlanta Center for Medical Research — Atlanta, Georgia, United States (enrolling)
• CenExel iResearch, LLC — Decatur, Georgia, United States (enrolling)
• Uptown Research Institute — Chicago, Illinois, United States (enrolling)
• Hassman Research Institute Marlton Site — Marlton, New Jersey, United States (enrolling)
• Community Clinical Research — Austin, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.