RecruitingPhase 1Phase 2NCT07660614

A Study of LTX-002 in Adult Participants With Amyotrophic Lateral Sclerosis

A First-in-Human, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study of Intrathecally Administered LTX-002 in Adult Participants With Amyotrophic Lateral Sclerosis

Sponsor

Leal Therapeutics, Inc

Enrollment

56 participants

Start Date

Apr 29, 2026

Study Type

INTERVENTIONAL

Conditions

Amyotrophic Lateral Sclerosis

Summary

This study will examine what happens when patients with amyotrophic lateral sclerosis (ALS) are given an investigational medication (study drug) known as LTX-002. Specifically, the researchers will be looking at safety, tolerability (if someone has any side effects from the drug), pharmacokinetics (what the body does to the study drug) and pharmacodynamics (what the study drug does to the body). The study will also investigate the effect of the drug on indicators of the severity of ALS, such as markers in blood and in the cerebrospinal fluid (the fluid that surrounds the brain and spinal cord, CSF) and on measures of the participant's ability to move, speak, and breathe.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called LTX-002 and Placebo (aCSF) for people with amyotrophic lateral sclerosis. The study is currently recruiting participants at 5 locations. People eligible for this study include aged 18 Years to 75 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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