SchizophreniaPhase 1NCT07061288
A Study to Evaluate the Safety, Tolerability, and PK of an Injectable Form of KarXT
A Phase 1 study testing KarXT in people with Schizophrenia, run by Bristol-Myers Squibb at 8 sites in United States.
Trial summary
A study to evaluate the safety, tolerability, and PK of an injectable form of KarXT in participants with schizophrenia Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- KarXT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 131 participants
- Where
- 8 sitesUnited States
- Study dates
- 3 Sep 2025to 15 Oct 2027
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact
First line of the email MUST contain NCT # and Site #. contact
8 sites in 1 country
United States8 sites, 8 recruiting
- Recruiting
Atlanta Center for Medical Research
Atlanta, Georgia, 30331
Elyssa Barron, Site 0008, 404-881-5800
- Recruiting
Community Clinical Research
Austin, Texas, 78754
David Brown, Site 0006, 512-323-2622
- Recruiting
Uptown Research Institute
Chicago, Illinois, 60640
John Sonnenberg, Site 0002, 773-968-9868
- Recruiting
CenExel iResearch, LLC
Decatur, Georgia, 30030
Kimball Johnson, Site 0003, 312-942-5592
- Recruiting
Research Centers of America ( Hollywood )
Hollywood, Florida, 33024
Edwin Gomez, Site 0005, 954-990-7649
- Recruiting
Collaborative Neuroscience Research, LLC
Los Alamitos, California, 90720-3118
David Walling, Site 0001, 714-799-7799
- Recruiting
Hassman Research Institute Marlton Site
Marlton, New Jersey, 08053
Elan Cohen, Site 0007, 856-452-9901
- Recruiting
Innovative Clinical Research, Inc.
Miami Lakes, Florida, 33016
Rishi Kakar, Site 0004, 786-512-4106
About this study
Official title: An Open-label, Phase 1, Dose-Finding Study to Characterize the Safety, Tolerability, and Pharmacokinetics of a Long-Acting Injectable KarXT Formulation in Participants With Schizophrenia
A study to evaluate the safety, tolerability, and PK of an injectable form of KarXT in participants with schizophrenia
- Conditions
- Schizophrenia
- Being tested
- KarXT
- Keywords
- KarXT, Long-acting injectable (LAI), Cobenfy
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KarXTDrug
Also called BMS-986510
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Administration of KarXT | Experimental | Not described Receives: Drug: KarXT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events (AEs)
Measured: Up to 3 weeks
Number of participants with adverse events of special interest (AESIs)
Measured: Up to 3 weeks
Number of participants with serious adverse events (SAEs)
Measured: Up to 3 weeks
Secondary outcomes (11)
Maximum concentration (Cmax)
Measured: Up to 15 weeks
Time to maximum concentration (Tmax)
Measured: Up to 15 weeks
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))
Measured: Up to 15 weeks
Area under the plasma concentration-time curve from time zero to infinity (AUC(INF))
Measured: Up to 15 weeks
Area under the plasma concentration-time curve from time zero to 672 hours (AUC(0-672))
Measured: Up to 15 weeks
Apparent terminal phase half-life (T-HALF)
Measured: Up to 15 weeks
Apparent total body clearance (CLT/F)
Measured: Up to 15 weeks
Apparent volume of distribution of terminal phase (Vz/F)
Measured: Up to 15 weeks
Number of participants with AEs
Measured: Up to 3 weeks
Number of participants with AESIs
Measured: Up to 3 weeks
Number of participants with SAEs
Measured: Up to 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2025
- Study start3 Sep 2025
- Primary completion21 Jun 2027 (estimated)
- Study completion15 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 131 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07061288
- Sponsor's protocol ID
- CN012-0016
- Status last verified
- Aug 2026
- First submitted
- 2 Jul 2025
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html