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NCT07734493
A Study of LTX-001 In Adult Participants With Acute Exacerbation of Schizophrenia
Conditions: Schizophrenia
Sex: All
Ages: 18 Years – 55 Years
Healthy volunteers: No
Phase: PHASE1
Enrollment: 90
Sponsor: Leal Therapeutics, Inc
Location: Pillar Clinical Research, LLC Little Rock Arkansas
Summary
The purpose of this clinical trial is to learn whether the investigational drug LTX-001 is safe and well tolerated in adults with a diagnosis of schizophrenia who are having a recent worsening of their symptoms (an acute exacerbation). Additional questions it aims to answer are:
* how does the amount of the study drug in the body change over time (pharmacokinetics)
* how does the study drug affect the symptoms of schizophrenia
* how do certain markers in the blood change after administration of LTX-001 (pharmacodynamics)
Researchers will compare different dose levels of LTX-001 to an inactive product (placebo) to see what differences there are between the two treatments.
After successfully screening for the study, participants will stay in a research unit for about five weeks and return one week later for a follow-up visit.
Eligibility Criteria
Inclusion Criteria:
* BMI \> 17.5 and \< 38.0 kg/m2 and a total body weight \> 50.0 kg (110 lbs)
* Primary diagnosis of schizophrenia per the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5-TR)
* Experiencing an acute exacerbation or relapse of symptoms, with onset less than 2 months prior to screening for the study
* PANSS total score ≥ 80 at the time of screening for the study
* Not currently on antipsychotic medication, or is willing to discontinue all prohibited psychotropic medications prior to and during the trial period
* Sexually active adults must be willing to use an acceptable contraceptive method throughout the study
Exclusion Criteria:
* Evidence of organ dysfunction or any clinically significant abnormal finding at physical examination
* History of treatment resistance (e.g., failure to respond to ≥ 2 adequate antipsychotic trials) or failure to respond to use of clozapine
* Current DSM-5-TR diagnosis other than schizophrenia
* Pregnant or lactating female
* Substance use disorder within 1 year prior to screening or recreational use of drugs within 3 months prior to screening
* Moderate to severe alcohol use disorder as per DSM-5-TR within the past year or excessive use of alcohol within 12 months prior to screening
* Positive testing for human immunodeficiency virus (HIV)-1 and -2 antibody, hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibody at screening
Source: ClinicalTrials.gov (NCT07734493). StuddyBuddy aggregates publicly available trial information.