A Study of LTX-001 In Adult Participants With Acute Exacerbation of Schizophrenia
A Phase 1b, Multicenter, Randomized, Double-Blind, Dose-Escalation, Placebo-Controlled Study to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, And Early Signs of Efficacy of Orally Administered LTX-001 As Monotherapy in Adult Participants With Acute Exacerbation of Schizophrenia
Leal Therapeutics, Inc
90 participants
Aug 1, 2026
INTERVENTIONAL
Conditions
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
Inclusion Criteria6
- 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 Criteria7
- 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
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Interventions
LTX-001 40 mg and 60 mg administered as oral suspension
Oral suspension without LTX-001
LTX-001 30 mg and 60 mg administered as oral suspension
Locations(10)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07734493