RightFit
RecruitingPhase 1

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 55 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests an injectable form of KarXT in people with schizophrenia. It looks at safety, how well people handle side effects, and how the drug moves through the body.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have schizophrenia as your main diagnosis, confirmed by a mental health exam and interview.
  • Have symptom scores of 80 or less on PANSS and 4 or less on CGI-S at screening and the starting visit. These scales measure how severe your symptoms are.
  • Have a body mass index (BMI) from 18 to 40. BMI is a measure based on height and weight.
  • Be willing and able to stop all antipsychotic medicines before the starting visit, as judged by the study doctor. These medicines treat symptoms such as seeing or hearing things that are not there.
  • Be able to follow all study requirements.

Who can't join

  • Have newly diagnosed schizophrenia or are being treated for a first episode.
  • Have had another mental health disorder diagnosed in the past 12 months, such as major depression or bipolar disorder.
  • Have had an alcohol or drug use disorder in the past 12 months.
  • Have a serious illness or disorder that could put your safety at risk or affect the study results.
  • Be at risk of suicidal behavior.
  • Be pregnant or breastfeeding.
  • Other study rules may also affect whether you can join.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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 sites (8)

CA

FL

GA

IL

NJ

TX