Clinical Trial

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

Recruiting Phase 1
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Summary
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.
Protocol Amendment History 1 change
critical Recruitment opened 2026-08-05
Trial Details
NCT Number NCT07734493
Lead Sponsor Leal Therapeutics, Inc
Conditions Schizophrenia
Enrollment 90 participants
Start Date 2026-08
Primary Completion 2027-03 (estimated)
Study Completion 2027-03 (estimated)
Updated on ClinicalTrials.gov 2026-08-11