MRG-001 in Patients With Amyotrophic Lateral Sclerosis

Sponsor
MedRegen LLC
Study ID
NCT06315608
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • MRG-001 — DRUG
    MRG-001 is a clear liquid solution for subcutaneous injection

Study Details

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.

Key Dates

First listed
Mar 18, 2024
Start date
Jul 1, 2025
Status verified
Aug 2024
Primary completion
Jan 1, 2026
Completion
Mar 1, 2026

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: MRG-001 (0.01 mL/kg)
    MRG-001 will be subcutaneously administered at 0.01 mL/kg 3 times per week every other day for two weeks per month (Day 0, 2, 4, 7, 9, 11). This cycle will be repeated 3 months in total.

Primary Outcome Measure

Assessment of Treatment-Emergent Adverse Events [ Time Frame: 3 Months ]

Central Contacts

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