Testing LTX-001, an oral drug, for adults whose schizophrenia has recently worsened
Tests the safety of LTX-001 in adults with worsening schizophrenia symptoms.
Plain-language title generated from the registry record
Registry title: A Study of LTX-001 In Adult Participants With Acute Exacerbation of Schizophrenia
Key facts
- Where
- Decatur, DeLand, Gaithersburg, Hollywood, Little Rock, Los Alamitos, Marlton, Miami Lakes, and Richardson, United StatesSee the 10 sites
- Phase
- Phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 55 years old?
Source: NCT07734493, who can take part
Where in United States
- CenExel iResearch, LLCDecatur, United StatesTaking people
- University Clinical Research-DeLand, LLC d/b/a Accel Research Sites - DeLand Clinical Research UnitDeLand, United StatesTaking people
- CBH Health LLC., dba CenExel Gaithersburg MDGaithersburg, United StatesTaking people
- Behavioral Clinical Research, Inc.Hollywood, United StatesTaking people
- CenExel Hollywood FLHollywood, United StatesTaking people
- Pillar Clinical Research, LLCLittle Rock, United StatesTaking people
- Collaborative Neuroscience Research, LLCLos Alamitos, United StatesTaking people
- Hassman Research Institute, LLCMarlton, United StatesTaking people
- Innovative Clinical Research, Inc.Miami Lakes, United StatesTaking people
- Pillar Clinical Research, LLCRichardson, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Leal Therapeutics, Inc
- Trial code
- NCT07734493
- Record updated
- 17 September 2026
- Original 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:Read full original descriptionShow less
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
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.
Inclusion: 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: 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; History of treatment resistance (e.g., failure to respond to ≥ 2 adequate antipsychotic trials) or failure to respond to use of clozapine; Positive testing for human immunodeficiency virus (HIV)-1 and -2 antibody, hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibody at screening; Evidence of organ dysfunction or any clinically significant abnormal finding at physical examination; Current DSM-5-TR diagnosis other than schizophrenia; Pregnant or lactating female.