Actively Recruiting
An Open-label, Phase 1, Single Ascending Dose Study to Assess Safety and Pharmacokinetics of Long-Acting Injectable KarXT in Schizophrenia
Led by Bristol-Myers Squibb · Updated on 2025-12-22
48
Participants Needed
8
Research Sites
16 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the dose levels, safety, and drug levels of KarXT given as a single intramuscular injection in adults with schizophrenia. This open-label Phase 1 study aims to understand how the long-acting injectable form of KarXT behaves in the body and how well it is tolerated by participants who meet specific clinical criteria. Participants will receive a specified dose of KarXT via intramuscular injection, with the study focusing on finding the right dose and monitoring safety. This includes tracking adverse events and measuring drug levels over time. The study is non-randomized and does not include a placebo group. During the study, participants will be monitored for adverse events up to 3 weeks after injection, and their blood will be tested for drug concentrations up to 15 weeks. They will undergo psychiatric evaluations and clinical assessments at screening and baseline, and must discontinue all other antipsychotic medications before starting the study. The total participation duration covers these monitoring periods to assess safety and pharmacokinetics comprehensively.
CONDITIONS
Brief Title
A Study to Evaluate the Dose Levels, Safety, and Drug Levels of Single KarXT Intramuscular Injection in Participants With Schizophrenia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must have a primary diagnosis of schizophrenia confirmed by DSM-5-TR criteria and MINI version 7.0.2
- Participants must have a PANSS total score of 80 or less and a CGI-S score of 4 or less at screening and baseline
- Participants must have a body mass index between 18 and 40 kg/m2
- Participants must be willing and able to stop all antipsychotic medications before baseline and comply with all protocol requirements
- Age between 18 and 55 years
- Both male and female participants are eligible
You will not qualify if you...
- Participants with newly diagnosed schizophrenia or first treated episode are excluded
- Participants with any other DSM-5-TR disorder diagnosed in the past 12 months, such as major depressive disorder or bipolar disorder, are excluded
- Participants with a history of alcohol or drug use disorder in the past 12 months or clinically significant disease affecting safety or study validity are excluded
- Participants at risk for suicidal behavior are excluded
- Female participants who are pregnant or breastfeeding are excluded
- Other protocol-defined inclusion/exclusion criteria apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 3 weeks
Participants receive a single intramuscular injection of KarXT at specified dose levels.
1 treatment visit and follow-up visits over 3 weeks
Duration - Up to 15 weeks
Participants are monitored for safety and drug levels after the single dose of KarXT.
Periodic visits for up to 15 weeks
Trial Site Locations
Total: 8 locations
1
Collaborative Neuroscience Research, LLC
Los Alamitos, California, United States, 90720-3118
Actively Recruiting
2
Research Centers of America ( Hollywood )
Hollywood, Florida, United States, 33024
Actively Recruiting
3
Innovative Clinical Research, Inc.
Miami Lakes, Florida, United States, 33016
Actively Recruiting
4
Atlanta Center for Medical Research
Atlanta, Georgia, United States, 30331
Actively Recruiting
5
CenExel iResearch, LLC
Decatur, Georgia, United States, 30030
Actively Recruiting
6
Uptown Research Institute
Chicago, Illinois, United States, 60640
Actively Recruiting
7
Hassman Research Institute Marlton Site
Marlton, New Jersey, United States, 08053
Actively Recruiting
8
Community Clinical Research
Austin, Texas, United States, 78754
Actively Recruiting
Research Team
B
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
F
First line of the email MUST contain the NCT# and Site#
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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