NCT06315608

MRG-001 in Patients With Amyotrophic Lateral Sclerosis

An Open-Label, Proof of Concept Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of MRG-001 in Patients With Amyotrophic Lateral Sclerosis

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: MedRegen LLC · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The proposed study is an Open-Label, Single-Dose Study to Assess the Safety, and Pharmacodynamics (PD) signals of MRG-001 in Patients with Amyotrophic Lateral Sclerosis (ALS). MRG-001 will be administered subcutaneously 3 times per week for 2 weeks. This cycle will be repeated for 3 months. In total, patients are expected to receive 18 injections over the span of 3 months.

Conditions

• Amyotrophic Lateral Sclerosis
• Lou Gehrig Disease
• Motor Neuron Disease
• Motor Neuron Atrophy

Interventions

Type	Name	Description
DRUG	MRG-001	MRG-001 is a clear liquid solution for subcutaneous injection

Timeline

• Start date: 2025-07-01
• Primary completion: 2026-01-01
• Completion: 2026-03-01
• First posted: 2024-03-18
• Last updated: 2024-08-23

Regulatory

• FDA-regulated drug study