RecruitingPhase 1NCT07061288
A Study to Evaluate the Dose Levels, Safety, and Drug Levels of Single KarXT Intramuscular Injection in Participants 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
Sponsor
Bristol-Myers Squibb
Enrollment
48 participants
Start Date
Sep 3, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
The purpose of this study is to evaluate the dose levels, safety, and drug levels of KarXT intramuscular injection in participants with Schizophrenia
Eligibility
Min Age: 18 YearsMax Age: 55 Years
Inclusion Criteria4
- 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 Criteria5
- 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.
Interventions
DRUGKarXT
Specified dose on specified days
Locations(8)
View Full Details on ClinicalTrials.gov
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NCT07061288
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