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Study identifier: NCT07734493 Synced from ClinicalTrials.gov · August 02, 2026
● Not Yet Recruiting

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

Condition: Schizophrenia  ·  Sponsor: Leal Therapeutics, Inc

PhasePhase 1
Planned participants90
Who can joinAll sexes, 18 Years to 55 Years
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Clinical Trials Information Medical Monitor  ·  267-503-4800  ·  clinical.trials@lealtx.com

Study Director Medical Monitor

Always discuss trial participation with your own doctor first.

Locations (10)

Pillar Clinical Research, LLCLittle Rock, Arkansas, United States
Collaborative Neuroscience Research, LLCLos Alamitos, California, United States
University Clinical Research-DeLand, LLC d/b/a Accel Research Sites - DeLand Clinical Research UnitDeLand, Florida, United States
Behavioral Clinical Research, Inc.Hollywood, Florida, United States
CenExel Hollywood FLHollywood, Florida, United States
Innovative Clinical Research, Inc.Miami Lakes, Florida, United States
CenExel iResearch, LLCDecatur, Georgia, United States
CBH Health LLC., dba CenExel Gaithersburg MDGaithersburg, Maryland, United States
Hassman Research Institute, LLCMarlton, New Jersey, United States
Pillar Clinical Research, LLCRichardson, Texas, United States

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