NCT05795465

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

A Phase 2, Two-Part Study to Evaluate the Safety and Tolerability of GEn-1124 in Subjects With Acute Respiratory Distress Syndrome (ARDS)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 52 (estimated)
• Sponsor: GEn1E Lifesciences · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Randomized , double-blind, placebo controlled, dose escalation study to evaluate the pharmacokinetics (PK), pharmacodynamics (PD), safety, and tolerability of GEn1124. GEn-1124 or placebo will be administered as a 2-hour IV infusion as early as possible after ARDS diagnosis. Participants will receive a second dose approximately 8 hours after the first and will continue BID for the remaining schedule (Days 2-5). Follow-up will be for a total of 60 days after the first dose or death (whichever comes first). An independent Safety Review Committee (SRC) will be responsible for reviewing data throughout the study.

Conditions

• Respiratory Distress Syndrome, Acute

Interventions

Type	Name	Description
DRUG	GEn-1124	Intravenous infusion
DRUG	Placebo	Intravenous infusion

Timeline

• Start date: 2023-04-04
• Primary completion: 2026-10-01
• Completion: 2026-12-01
• First posted: 2023-04-03
• Last updated: 2025-10-22

Locations

11 sites across 1 country: United States

Regulatory

• FDA-regulated drug study