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

NCT07734493 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2026-08-11

No results posted yet for this study

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.

Conditions

Interventions

DRUG

LTX-001 once daily

LTX-001 40 mg and 60 mg administered as oral suspension

DRUG

Placebo

Oral suspension without LTX-001

DRUG

LTX-001 twice daily

LTX-001 30 mg and 60 mg administered as oral suspension

Sponsors & Collaborators

  • Leal Therapeutics, Inc

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2027-03-31
Completion
2027-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07734493 on ClinicalTrials.gov