Safety and Effectiveness Study of Single-Dose Inhaled Recombinant Human Keratinocyte Growth Factor-2 for Treating Acute Respiratory Distress Syndrome in Adults

What this Trial Is About

Researchers are evaluating the safety, tolerability, and effectiveness of recombinant human keratinocyte growth factor-2 rhKGF-2 inhalation in patients with moderate or severe acute respiratory distress syndrome ARDS. This early phase 1 clinical trial uses a randomized, open-label, dose-escalation design with three dose groups to study these effects. The study aims to understand how well this treatment works alongside standard ARDS care and to monitor for any adverse reactions or changes in lung function and overall health. Participants will be assigned to one of three dose groups 5 mg, 10 mg, or 15 mg of rhKGF-2 or a blank control group, with each group enrolling 8 subjects in a 62 ratio. Each participant receives a single dose administered once through a disposable bronchoscopic catheter. The treatment is given in addition to standard ARDS therapy. After dosing, participants enter a 28-day follow-up period to monitor their response and safety. During the study and follow-up, researchers will regularly assess participants vital signs, laboratory tests including blood parameters, oxygenation index, chest imaging, and any adverse events. These assessments happen at multiple time points up to 28 days after treatment. The study will measure lung function improvements and safety markers to evaluate the impact of the treatment. Participants health status will be monitored carefully throughout to ensure safety and collect important data about the therapys effects.

A Single Dose, Dose Escalation Clinical Trial on the Safety, Tolerability and Efficacy of Lyophilized Powder for Inhalation of Recombinant Human Keratinocyte Growth Factor-2 (Rh-KGF-2) in The Treatment of Patients With Acute Respiratory Distress Syndrome