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RecruitingPhase 1

A Study to Evaluate the Safety, Tolerability, and PK of an Injectable Form of KarXT

Bristol-Myers Squibb · NCT07061288

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–55 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 1
Target enrollment
131
US sites recruiting
8
Study start
September 3, 2025
Record last updated
September 2, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

A study to evaluate the safety, tolerability, and PK of an injectable form of KarXT in participants with schizophrenia

Being studied: KarXT

Conditions: Schizophrenia

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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.

Recruiting US locations

  • Collaborative Neuroscience Research, LLC

    Los Alamitos, CA 90720-3118

    Site contact: David Walling, Site 0001 · 714-799-7799

  • Research Centers of America ( Hollywood )

    Hollywood, FL 33024

    Site contact: Edwin Gomez, Site 0005 · 954-990-7649

  • Innovative Clinical Research, Inc.

    Miami Lakes, FL 33016

    Site contact: Rishi Kakar, Site 0004 · 786-512-4106

  • Atlanta Center for Medical Research

    Atlanta, GA 30331

    Site contact: Elyssa Barron, Site 0008 · 404-881-5800

  • CenExel iResearch, LLC

    Decatur, GA 30030

    Site contact: Kimball Johnson, Site 0003 · 312-942-5592

  • Uptown Research Institute

    Chicago, IL 60640

    Site contact: John Sonnenberg, Site 0002 · 773-968-9868

  • Hassman Research Institute Marlton Site

    Marlton, NJ 08053

    Site contact: Elan Cohen, Site 0007 · 856-452-9901

  • Community Clinical Research

    Austin, TX 78754

    Site contact: David Brown, Site 0006 · 512-323-2622

Study contacts (from the official record)

  • BMS Clinical Trials Contact Center www.BMSClinicalTrials.com · 855-907-3286 · Clinical.Trials@bms.com
  • First line of the email MUST contain NCT # and Site #.
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A Study to Evaluate the Safety, Tolerability, and PK of an… (NCT07061288) | Bored Studies