RecruitingPhase 1NCT05279755

A Study to Evaluate the Safety and Pharmacokinetics of Single and Multiple Doses of Prosetin in Healthy Volunteers and Participants With ALS

A Phase 1, Randomized, Double-Blind, Placebo-Controlled Dose Escalating Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending and Multiple Ascending Doses of Prosetin in Healthy Volunteers and Participants With Amyotrophic Lateral Sclerosis (ALS) With an Optional Open-Label Extended Treatment Period for ALS Participants Who Complete 14 Days of Blinded Treatment


Sponsor

ProJenX

Enrollment

72 participants

Start Date

Feb 26, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

The primary purpose of this study is to evaluate the safety and tolerability of prosetin in healthy volunteers and participants with ALS.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new oral drug called Prosetin (NRC-2694-A) for people with ALS (also known as Lou Gehrig's disease), a progressive neurological condition that affects movement. The study is evaluating whether the drug is safe and how it behaves in the body. **You may be eligible if...** - You are 18 or older and have a confirmed diagnosis of ALS - Your lung function is above 50% of normal - You are able to swallow liquids to take the study medication - If you take riluzole or other approved ALS medications, your dose has been stable for at least 30 days **You may NOT be eligible if...** - You have significant dementia or another neurological disease besides ALS - You have had episodes of vertigo in the past year or a history of seizures - You have had cancer in the past 5 years (certain exceptions may apply) - You have previously received stem cell or gene therapy for ALS - You are currently in another clinical drug trial Talk to your doctor to see if this trial is right for you.

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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Interventions

DRUGprosetin

oral solution

DRUGplacebo

oral solution


Locations(4)

Massachusetts General Hospital

Boston, Massachusetts, United States

Worldwide Clinical Trials Early Phase Services

San Antonio, Texas, United States

The Neuro - Montréal Neurological Institute-Hospital

Montreal, Quebec, Canada

University Medical Center Utrecht

Utrecht, Utrecht, Netherlands

View Full Details on ClinicalTrials.gov

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NCT05279755


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