Ireland
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Recruiting Phase 1

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

NCT07061288 · tracked via the Priya Life Science USA tracker
Phase
Phase 1
Started
2025-09-03
Last updated
2026-09-02

Condition(s) studied

Schizophrenia

Investigational drug(s) / intervention(s)

KarXT →

KarXT: Specified dose on specified days

Study summary

A study to evaluate the safety, tolerability, and PK of an injectable form of KarXT in participants with schizophrenia

Eligibility

Sex
ALL
Min age
18 Years
Max age
55 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • 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

Trial sites (8)

FacilityCityRegionStatus
Collaborative Neuroscience Research, LLC Los Alamitos California Recruiting
Research Centers of America ( Hollywood ) Hollywood Florida Recruiting
Innovative Clinical Research, Inc. Miami Lakes Florida Recruiting
Atlanta Center for Medical Research Atlanta Georgia Recruiting
CenExel iResearch, LLC Decatur Georgia Recruiting
Uptown Research Institute Chicago Illinois Recruiting
Hassman Research Institute Marlton Site Marlton New Jersey Recruiting
Community Clinical Research Austin Texas Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07061288 on ClinicalTrials.gov ↗ ← All trials in the USA