RECRUITING Phase 1 ClinicalTrials.gov

A Study of LTX-001 In Adult Participants With Acute Exacerbation of Schizophrenia

Sponsor: Leal Therapeutics, Inc • ClinicalTrials.gov ID: NCT07734493

Registry updated: 2026-09-17

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Description

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.

Interventions

LTX-001 once daily (Drug)
LTX-001 40 mg and 60 mg administered as oral suspension
Placebo (Drug)
Oral suspension without LTX-001
LTX-001 twice daily (Drug)
LTX-001 30 mg and 60 mg administered as oral suspension

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

Conditions

Schizophrenia

Locations

Pillar Clinical Research, LLC — Little Rock, Arkansas, United States
Collaborative Neuroscience Research, LLC — Los Alamitos, California, United States
University Clinical Research-DeLand, LLC d/b/a Accel Research Sites - DeLand Clinical Research Unit — DeLand, Florida, United States
Behavioral Clinical Research, Inc. — Hollywood, Florida, United States
CenExel Hollywood FL — Hollywood, Florida, United States
Innovative Clinical Research, Inc. — Miami Lakes, Florida, United States
CenExel iResearch, LLC — Decatur, Georgia, United States
CBH Health LLC., dba CenExel Gaithersburg MD — Gaithersburg, Maryland, United States
Hassman Research Institute, LLC — Marlton, New Jersey, United States
Pillar Clinical Research, LLC — Richardson, Texas, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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