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

Recruiting now · Phase 1 · Has a placebo group

Conditions studied: Schizophrenia

In brief

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.

Key facts

Study ID

NCT07734493

Run by

Leal Therapeutics, Inc

People needed

90

Starts

2026-08-01

Expected to finish

2027-03-01

Last updated by the study team

2026-08-04

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Innovative Clinical Research, Inc. — Miami Lakes, Florida, United States (enrolling)
• CenExel iResearch, LLC — Decatur, Georgia, United States (enrolling)
• Collaborative Neuroscience Research, LLC — Los Alamitos, California, United States (enrolling)
• Hassman Research Institute, LLC — Marlton, New Jersey, United States (enrolling)
• CenExel Hollywood FL — Hollywood, Florida, United States (enrolling)
• Pillar Clinical Research, LLC — Richardson, Texas, 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
• CBH Health LLC., dba CenExel Gaithersburg MD — Gaithersburg, Maryland, United States
• Pillar Clinical Research, LLC — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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