Trials / Not Yet Recruiting
Not Yet RecruitingNCT06308926
MRG-001 as an Immunoregulatory and Regenerative Therapy for ARDS Patients
A Phase IIa, Double-Blind, Randomized, Multi-Center Study Comparing MRG-001 to Placebo in Patients With Acute Respiratory Distress Syndrome
- Status
- Not Yet Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- Sponsor
- MedRegen LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a phase IIa, dose-ranging, proof-of-concept study of MRG-001 in patients with ARDS. The aim is to determine the safety and preliminary efficacy of MRG-001 across two dose ranges.
Conditions
- Acute Respiratory Distress Syndrome
- Respiratory Failure
- Respiratory Distress Syndrome
- Respiratory Tract Diseases
- Cytokine Storm
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | MRG-001 (Low-dose) | MRG-001 is subcutaneously administered. |
| DRUG | MRG-001 (High-dose) | MRG-001 is subcutaneously administered. |
| OTHER | Placebo | Saline placebo will be administered subcutaneously based on bodyweight and similar dose as the treatment group. |
Timeline
- Start date
- 2024-12-01
- Primary completion
- 2026-02-01
- Completion
- 2026-07-01
- First posted
- 2024-03-13
- Last updated
- 2024-08-23
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06308926. Inclusion in this directory is not an endorsement.