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NCT05795465 · ClinicalTrials.gov registry record · Phase 2
A Study of GEn-1124 in Subjects With Acute Respiratory Distress Syndrome (ARDS)
A Phase 2 study of Respiratory Distress Syndrome, Acute, sponsored by GEn1E Lifesciences.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 52
- Enrollment target
- 11
- Study locations
NCT05795465 is a Phase 2 study of Respiratory Distress Syndrome, Acute that is actively recruiting participants, run by GEn1E Lifesciences. The registered enrollment target is 52 participants. The trial reports 11 study locations across 10 states.
The verdict
NCT05795465, a Phase 2 study of Respiratory Distress Syndrome, Acute, is actively recruiting participants, sponsored by GEn1E Lifesciences.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 52 participants
- Enrollment target
- 11
- Study locations
Study Summary
GEn1E-1124-002 is a two-part Phase 2 study to evaluate the safety and tolerability of GEn-1124 in subjects with ARDS. Treatment with IV infusion dosing as early as possible after ARDS diagnosis. Subjects will be given a second dose approximately 8 hours after the first dose and will continue with twice daily dosing (BID regimen) for 5 days.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG GEn-1124
Study Locations (11)
Maryland
- University of Maryland Medical Center - Baltimore
- University of Maryland - Baltimore Washington Medical Center - Glen Burnie
District of Columbia
- Medstar Washington Hospital Center - Washington D.C.
Kansas
- University of Kansas Medical Center - Kansas City
Mississippi
- Ocean Springs Hospital - Ocean Springs
Missouri
- Washington University School of Medicine - St Louis
New Jersey
- Cooper University Hospital - Camden
New York
- The Mount Sinai Hospital - New York
Ohio
- Cleveland Clinic - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2023-04-04 |
| Est. Completion | 2026-12 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05795465
The ClinicalTrials.gov registry entry for NCT05795465 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 52 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GEn1E Lifesciences, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Respiratory Distress Syndrome, Acute appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05795465 reports 11 study locations spanning 10 distinct geographic areas - top geographies include Maryland, District of Columbia, Kansas.
Frequently Asked Questions
What is clinical trial NCT05795465 about?
NCT05795465 is a clinical study titled "A Study of GEn-1124 in Subjects With Acute Respiratory Distress Syndrome (ARDS)". GEn1E-1124-002 is a two-part Phase 2 study to evaluate the safety and tolerability of GEn-1124 in subjects with ARDS. Treatment with IV infusion dosing as early as possible after ARDS diagnosis. Subjects will be given a second dose approximately 8 hours after the first dose and will continue with tw...
What is the current status of trial NCT05795465?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 52 participants. The study started on 2023-04-04. Estimated completion is 2026-12.
What conditions does trial NCT05795465 study?
This clinical trial studies the following conditions: Respiratory Distress Syndrome, Acute.
What interventions are being tested in trial NCT05795465?
The interventions under investigation include: Placebo (DRUG), GEn-1124 (DRUG).
Who is sponsoring clinical trial NCT05795465?
This trial is sponsored by GEn1E Lifesciences, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05795465 being conducted?
This trial has 11 study locations across District of Columbia, Kansas, Maryland, Mississippi, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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