RecruitingPhase 1NCT07061288

A Study to Evaluate the Dose Levels, Safety, and Drug Levels of Single KarXT Intramuscular Injection in Participants With Schizophrenia

An Open-label, Phase 1, Single Ascending Dose-Finding Study to Characterize the Safety, Tolerability, and Pharmacokinetics of a Long Acting Injectable KarXT Formulation in Participants With Schizophrenia


Sponsor

Bristol-Myers Squibb

Enrollment

48 participants

Start Date

Sep 3, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to evaluate the dose levels, safety, and drug levels of KarXT intramuscular injection in participants with Schizophrenia


Eligibility

Min Age: 18 YearsMax Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a single intramuscular injection (a shot given into the muscle) of KarXT, an investigational medication for schizophrenia, to evaluate its safety, side effects, and how the drug moves through the body. KarXT works through a different mechanism than most antipsychotics. **You may be eligible if...** - You have been diagnosed with schizophrenia based on psychiatric evaluation using DSM-5-TR criteria - Your schizophrenia symptoms are not excessively severe (PANSS total score at or below 80) - You are an adult who can provide informed consent - You are stable enough to participate in a single-dose study **You may NOT be eligible if...** - You have another primary psychiatric diagnosis (other than schizophrenia) - You have unstable or serious medical conditions (heart, kidney, liver problems) - You have a history of serious adverse reactions to medications with similar mechanisms - You are pregnant or breastfeeding - You have used certain other medications recently that could interact with the study drug Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGKarXT

Specified dose on specified days


Locations(8)

Collaborative Neuroscience Research, LLC

Los Alamitos, California, United States

Research Centers of America ( Hollywood )

Hollywood, Florida, United States

Innovative Clinical Research, Inc.

Miami Lakes, Florida, United States

Atlanta Center for Medical Research

Atlanta, Georgia, United States

CenExel iResearch, LLC

Decatur, Georgia, United States

Uptown Research Institute

Chicago, Illinois, United States

Hassman Research Institute Marlton Site

Marlton, New Jersey, United States

Community Clinical Research

Austin, Texas, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT07061288


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