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

NCT05795465 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2025-10-22

No results posted yet for this 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

  • Respiratory Distress Syndrome, Acute

Interventions

DRUG

GEn-1124

Intravenous infusion

DRUG

Placebo

Intravenous infusion

Sponsors & Collaborators

  • GEn1E Lifesciences

    lead INDUSTRY

Principal Investigators

  • Ritu Lal, PhD, MS · GEn1E Lifesciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-04
Primary Completion
2026-10-31
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05795465 on ClinicalTrials.gov