Long-Acting Injectable KarXT Formulation for Schizophrenia
This early-stage study examines the safety and tolerability of a new long-acting injectable formulation of KarXT for treating schizophrenia, focusing on tracking any side effects or serious adverse events in participants.
KarXT
Mental Disorders
+ Schizophrenia
+ Schizophrenia Spectrum and Other Psychotic Disorders
Treatment Study
Summary
Study start date: September 3, 2025
Actual date on which the first participant was enrolled.This study is focused on assessing a new way to deliver a medication called KarXT for individuals diagnosed with schizophrenia. Schizophrenia is a mental health condition that affects a person's ability to think clearly, manage emotions, and interact with others. The study looks at how safe and well-tolerated different doses of KarXT are when given as an injection into the muscle. It aims to understand how the body processes the medication, which is crucial for determining the right dosage. This information could potentially lead to better treatment options for managing symptoms of schizophrenia. Participants in the study will receive a single injection of KarXT directly into the muscle. Researchers will observe these participants to see how their bodies respond to the treatment, focusing on any side effects or changes in health status. The study will not only measure drug levels in the body over time but also carefully monitor safety and any adverse reactions. By understanding the effects of this treatment, the study seeks to find a safe and effective dose that could improve the lives of those living with schizophrenia.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.48 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 55 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 8 locations
Collaborative Neuroscience Research, LLC
Los Alamitos, United StatesOpen Collaborative Neuroscience Research, LLC in Google MapsResearch Centers of America ( Hollywood )
Hollywood, United StatesInnovative Clinical Research, Inc.
Miami Lakes, United StatesAtlanta Center for Medical Research
Atlanta, United States