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
Bristol-Myers Squibb
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
- Age range
- 18–55 years
- Sex
- All
- Healthy volunteers
- No
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 an…
Interventions
- DrugKarXT
Specified dose on specified days
Locations (8)
- Collaborative Neuroscience Research, LLCLos Alamitos, California
- Research Centers of America ( Hollywood )Hollywood, Florida
- Innovative Clinical Research, Inc.Miami Lakes, Florida
- Atlanta Center for Medical ResearchAtlanta, Georgia
- CenExel iResearch, LLCDecatur, Georgia
- Uptown Research InstituteChicago, Illinois