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Study of Injectable KarXT for Schizophrenia

This study is looking at an injectable form of KarXT to see how safe it is and how well your body handles it. It's for people aged 18 to 55 who have been diagnosed with schizophrenia. The main goal is to track any side effects (adverse events) that happen up to three weeks after receiving KarXT. We don't know the current recruitment status, but the study plans to include about 116 participants.

Study design
This is an interventional study planning to enroll 116 participants. The phase of the study is not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for adverse events for up to 3 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07061288

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

Recruiting
PHASE1Ages 18–55InterventionalTreatment
Bristol-Myers Squibb
~116 participants
Updated 2026-06-12 on ClinicalTrials.gov
What's tested:KarXT

At a glance

Recruiting sites
8 of 8 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with adverse events (AEs)
Measured over Up to 3 weeks
+2 more outcomes measured

Conditions

Schizophrenia

Explore related trials

Schizophrenia

Where it's being run

8 sites across 6 states
Florida2
Georgia2
California1
Illinois1
New Jersey1
Texas1

Study leadership

  • Bristol-Myers Squibb · STUDY_DIRECTOR · Bristol-Myers Squibb

Who to contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
[email protected]
855-907-3286
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Number of participants with adverse events (AEs)Up to 3 weeks
  • Number of participants with adverse events of special interest (AESIs)Up to 3 weeks
  • Number of participants with serious adverse events (SAEs)Up to 3 weeks