NCT07734493RecruitingPhase 1
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
Source: ClinicalTrials.gov · Last updated 17 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- First submitted
- 20 Jul 2026
- Start date
- 3 Aug 2026
- Primary completion date
- Mar 2027
- Lead sponsor
- Leal Therapeutics, Inc
- Diseases
- Schizophrenia
- NCT number
- NCT07734493
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 90
- From 3 Aug 2026 to the primary completion date, Mar 2027
- 10 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 55 years · Sex: All · Does not accept healthy volunteers
Sites (10)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CenExel iResearch, LLC Coordinator of this site? Confirm its status | Decatur | United States | Recruiting |
| University Clinical Research-DeLand, LLC d/b/a Accel Research Sites - DeLand Clinical Research Unit Coordinator of this site? Confirm its status | DeLand | United States | Recruiting |
| CBH Health LLC., dba CenExel Gaithersburg MD Coordinator of this site? Confirm its status | Gaithersburg | United States | Recruiting |
| Behavioral Clinical Research, Inc. Coordinator of this site? Confirm its status | Hollywood | United States | Recruiting |
| CenExel Hollywood FL Coordinator of this site? Confirm its status | Hollywood | United States | Recruiting |
| Pillar Clinical Research, LLC Coordinator of this site? Confirm its status | Little Rock | United States | Recruiting |
| Collaborative Neuroscience Research, LLC Coordinator of this site? Confirm its status | Los Alamitos | United States | Recruiting |
| Hassman Research Institute, LLC Coordinator of this site? Confirm its status | Marlton | United States | Recruiting |
| Innovative Clinical Research, Inc. Coordinator of this site? Confirm its status | Miami Lakes | United States | Recruiting |
| Pillar Clinical Research, LLC Coordinator of this site? Confirm its status | Richardson | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.