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

Respiratory Distress Syndrome, Acute Clinical Trial

Official title: 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

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Acute Lung Injury
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Acute
• Respiratory Distress Syndrome, Newborn
• Syndrome

• NCT number: NCT05795465
• Study type: Interventional
• Source: GEn1E Lifesciences
• Contact: Ritu Lal, PhD, MS
• Phone: 650-485-3279
• Email: clinical@gen1elifesci.com
• Status: Recruiting
• Phase: Phase 2
• Start date: April 4, 2023
• Completion date: July 2024