A Study to Evaluate the Safety and Pharmacokinetics of Single and Multiple Doses of Prosetin in Healthy Volunteers and Participants With ALS (NCT05279755)
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
🩺 Plain-English Summary (8th-Grade Level)
The primary purpose of this study is to evaluate the safety and tolerability of prosetin in healthy volunteers and participants with ALS.
Who can join: Review the eligibility criteria below.
Location: Massachusetts General Hospital — Boston, Massachusetts
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (4 Sites)
- Massachusetts General Hospital — Boston, Massachusetts
- Worldwide Clinical Trials Early Phase Services — San Antonio, Texas
- The Neuro - Montréal Neurological Institute-Hospital — Montreal, Quebec
- University Medical Center Utrecht — Utrecht, Utrecht
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Amyotrophic Lateral Sclerosis
- Intravenous Immunoglobulin (IVIG) and Blood-Brain Barrier Disruption in Amyotrophic Lateral Sclerosis (ALS) — Toronto, Ontario
- Regulatory T Cells for Amyotrophic Lateral Sclerosis — New York, New York
- Rho Kinase Inhibitor in Amyotrophic Lateral Sclerosis (REAL) — Phoenix, Arizona
- TRIAL READY (Clinical Trial Readiness) — Miami, Florida
- Phase III Trial of AMX0035 for Amyotrophic Lateral Sclerosis Treatment — Phoenix, Arizona
- Personalized Antisense Oligonucleotide for a Single Participant With CHCHD10 ALS — New York, New York
Explore by condition: All Amyotrophic Lateral Sclerosis clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.