Phase 2 Study to Test Safety and Tolerability of GEn-1124 IV Treatment in Adults With Acute Respiratory Distress Syndrome ARDS

What this Trial Is About

Researchers are conducting a two-part Phase 2 study to evaluate the safety and tolerability of GEn-1124 in adults diagnosed with Acute Respiratory Distress Syndrome ARDS. The study is randomized, double-blind, and placebo-controlled with dose escalation to assess how the drug behaves in the body and its effects compared to placebo. An independent Safety Review Committee will monitor data throughout the study to ensure participant safety. Participants will receive GEn-1124 or placebo as a 2-hour intravenous infusion as soon as possible after ARDS diagnosis. A second dose will be given about 8 hours after the first, followed by twice daily dosing for five days. The study includes low and high dose groups in the first part and additional dosing in the second part depending on earlier results. During the study, participants will be closely monitored for safety and tolerability for up to 60 days after the first dose or until death if earlier. Researchers will assess serious adverse events and other side effects. The study involves multiple visits for treatment and follow-up, with data collected on how participants respond to the drug over time.

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