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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
Who can join
Ages 18 to 55 · All sexes
Full 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
About the study
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.
What is being tested
- LTX-001 once daily (drug)
- Placebo (drug)
- LTX-001 twice daily (drug)
Sponsor: Leal Therapeutics, Inc · Participants: 90 · Started: Aug 3, 2026
Contact the study team
- Clinical Trials Information Medical Monitor · Phone: 267-503-4800
Official record on ClinicalTrials.gov — NCT07734493
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.