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

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor
Leal Therapeutics, Inc
Study ID
NCT07734493
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Not accepted

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

Study Details

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 Dates

First listed
Jul 29, 2026
Start date
Aug 31, 2026
Status verified
Aug 2026
Primary completion
Mar 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo
    Placebo
  • Experimental: LTX-001 once daily
    LTX-001
  • Experimental: LTX-001 twice daily
    LTX-001

Primary Outcome Measure

Safety and Tolerability - Adverse Events [ Time Frame: Screening through Day 42 ]

Central Contacts

  • Clinical Trials Information Medical Monitor
    267-503-4800
    [email protected]
  • Study Director Medical Monitor

Locations (10)

FacilityCityStateZIPSite coordinators
Pillar Clinical Research, LLCLittle RockArkansas72204
Leslie Smith
[email protected]
Leslie Smith, MD (PRINCIPAL_INVESTIGATOR)
Collaborative Neuroscience Research, LLCLos AlamitosCalifornia90720
Study Recruiter
(714)-891-0971
David Walling, PhD (PRINCIPAL_INVESTIGATOR)
University Clinical Research-DeLand, LLC d/b/a Accel Research Sites - DeLand Clinical Research UnitDeLandFlorida32720
Bruce Rankin
[email protected]
Bruce Rankin, MD (PRINCIPAL_INVESTIGATOR)
Behavioral Clinical Research, Inc.HollywoodFlorida33021
Leandro Rueda
[email protected]
Olga Lapeyra, MD (PRINCIPAL_INVESTIGATOR)
CenExel Hollywood FLHollywoodFlorida33024
Edwin A Gomez
954-990-7649
Edwin A Gomez, MD (PRINCIPAL_INVESTIGATOR)
Innovative Clinical Research, Inc.Miami LakesFlorida33016
Leandro Rueda
[email protected]
Rishi Kakar, MD (PRINCIPAL_INVESTIGATOR)
CenExel iResearch, LLCDecaturGeorgia30030
Michael Mahaffey
[email protected]
Kimball Johnson, MD (PRINCIPAL_INVESTIGATOR)
CBH Health LLC., dba CenExel Gaithersburg MDGaithersburgMaryland20877
Elia Acevedo-Diaz
301-251-4702
Elia Acevedo-Diaz, MD (PRINCIPAL_INVESTIGATOR)
Hassman Research Institute, LLCMarltonNew Jersey08053
Lisa Wilkins
[email protected]
888-437-4104
Elan Cohen, MD (PRINCIPAL_INVESTIGATOR)
Pillar Clinical Research, LLCRichardsonTexas75080
Scott Bartley
[email protected]
Scott Bartley, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Pillar Clinical Research, LLC· Little Rock, ARCollaborative Neuroscience Research, LLC· Los Alamitos, CAUniversity Clinical Research-DeLand, LLC d/b/a Accel Research Sites - DeLand Clinical Research Unit· DeLand, FLBehavioral Clinical Research, Inc.· Hollywood, FLCenExel Hollywood FL· Hollywood, FLInnovative Clinical Research, Inc.· Miami Lakes, FL

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