Clinical Trial

A Study of GEn-1124 in Subjects With Acute Respiratory Distress Syndrome (ARDS)

Recruiting Phase 2
View on ClinicalTrials.gov →
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.
Protocol Amendment History 13 amendments
This ClinicalTrials.gov record has been amended 13 times since 2023-03-20; most recent amendment 2026-06-18.
Status change: Not Yet Recruiting → Recruiting 2023-04-03
Trial Details
NCT Number NCT05795465
Lead Sponsor GEn1E Lifesciences
Conditions Respiratory Distress Syndrome, Acute
Enrollment 52 participants
Start Date 2023-04-04
Primary Completion 2026-10 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2026-06-23