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

Bristol-Myers Squibb (BMS)

Status and phase: Enrolling; Phase 1

Conditions: Schizophrenia

Treatments: Drug: KarXT

Study type: Interventional

Funder types: Industry

Identifiers

NCT07061288

CN012-0016

Details and patient eligibility

About

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

Enrollment: 48 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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48 participants in 1 patient group

Administration of KarXT

Experimental group

Treatment:

Drug: KarXT