NCT07061288 A Study to Evaluate the Safety, Tolerability, and PK of an Injectable Form of KarXT
| NCT ID | NCT07061288 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Bristol-Myers Squibb |
| Condition | Schizophrenia |
| Study Type | INTERVENTIONAL |
| Enrollment | 116 participants |
| Start Date | 2025-09-03 |
| Primary Completion | 2027-06-21 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 116 participants in total. It began in 2025-09-03 with a primary completion date of 2027-06-21.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
A study to evaluate the safety, tolerability, and PK of an injectable form of KarXT in participants with schizophrenia
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.
Contact & Investigator
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
✉ Clinical.Trials@bms.com📞 855-907-3286
Bristol-Myers Squibb
STUDY DIRECTOR
Bristol-Myers Squibb
Frequently Asked Questions
Who can join the NCT07061288 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 55 Years, studying Schizophrenia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07061288 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07061288 currently recruiting?
Yes, NCT07061288 is actively recruiting participants. Contact the research team at Clinical.Trials@bms.com for enrollment information.
Where is the NCT07061288 trial being conducted?
This trial is being conducted at Los Alamitos, United States, Hollywood, United States, Miami Lakes, United States, Atlanta, United States and 4 additional locations.
Who is sponsoring the NCT07061288 clinical trial?
NCT07061288 is sponsored by Bristol-Myers Squibb. The principal investigator is Bristol-Myers Squibb at Bristol-Myers Squibb. The trial plans to enroll 116 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.