drugset / Trial / NCT05795465

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

NCT05795465 ↗

Phase 2 Recruiting 52 enrolled GEn1E Lifesciences
RandomizedSequentialTriple-blindTreatment

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.

Timeline

Start
2023-04-04
Primary completion
2026-10
Completion
2026-12

Drugs

EvaluationDrugModalityDoseRoute
Subject GEn-1124 Unknown — Intravenous