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Trial ID CN012-0016  |   NCT07061288

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

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Summary

  • Phase 1
  • Male and Female Gender icon
  • 18-55
    Age Range
  • 8
    Locations
  • BMS Not Yet Recruiting Study icon
    Not Yet Recruiting

Overview

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

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Key Eligibility Criteria

Inclusion Criteria

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  • 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).
    1. Participants must have a Positive and Negative Syndrome Scale (PANSS) total score ≤ 80 and a Clinical Global Impression
      1. Severity (CGI-S) score ≤ 4 at both screening and baseline.
        1. Participants must have a body mass index (BMI) between 18 and 40 kg/m².
          1. 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

            Exclusion Criteria Icon
            • Participants must not have newly diagnosed schizophrenia or a first treated episode of schizophrenia.
              1. Participants must not have any other DSM-5-TR disorder diagnosed within the past 12 months, such as major depressive disorder or bipolar disorder.
                1. 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.
                  1. Participants must not be at risk for suicidal behavior.
                    1. Female participants must not be pregnant or breastfeeding.
                      Additional Information *
                      • Other protocol-defined Inclusion/Exclusion criteria apply.

                        Treatment Options

                        Study Arms

                        ASSIGNED INTERVENTION

                        Study Arms

                        Experimental: Administration of KarXT

                        ASSIGNED INTERVENTION
                        • Drug: KarXT
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