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RecruitingPhase 1Mentions an overnight / inpatient stay

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

Leal Therapeutics, Inc · NCT07734493

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–55 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 1
Target enrollment
90
US sites recruiting
10
Study start
August 3, 2026
Record last updated
September 17, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: LTX-001 once daily; Placebo; LTX-001 twice daily

Conditions: Schizophrenia

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

  • Pillar Clinical Research, LLC

    Little Rock, AR 72204

    Site contact: Leslie Smith · Studies@pillarhc.com

  • Collaborative Neuroscience Research, LLC

    Los Alamitos, CA 90720

    Site contact: Study Recruiter · (714)-891-0971

  • University Clinical Research-DeLand, LLC d/b/a Accel Research Sites - DeLand Clinical Research Unit

    DeLand, FL 32720

    Site contact: Bruce Rankin · bruce.rankin@accelclinical.com

  • Behavioral Clinical Research, Inc.

    Hollywood, FL 33021

    Site contact: Leandro Rueda · lrueda@segaltrials.com

  • CenExel Hollywood FL

    Hollywood, FL 33024

    Site contact: Edwin A Gomez · 954-990-7649

  • Innovative Clinical Research, Inc.

    Miami Lakes, FL 33016

    Site contact: Leandro Rueda · lrueda@segaltrials.com

  • CenExel iResearch, LLC

    Decatur, GA 30030

    Site contact: Michael Mahaffey · m.mahaffey@cenexel.com

  • CBH Health LLC., dba CenExel Gaithersburg MD

    Gaithersburg, MD 20877

    Site contact: Elia Acevedo-Diaz · 301-251-4702

  • Hassman Research Institute, LLC

    Marlton, NJ 08053

    Site contact: Lisa Wilkins · 888-437-4104 · L.Wilkins@CenExel.com

  • Pillar Clinical Research, LLC

    Richardson, TX 75080

    Site contact: Scott Bartley · studies@pillarhc.com

Study contacts (from the official record)

  • Clinical Trials Information Medical Monitor · 267-503-4800 · clinical.trials@lealtx.com
  • Study Director Medical Monitor
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A Study of LTX-001 In Adult Participants With Acute Exacerbation… (NCT07734493) | Bored Studies