drugset / Trial / NCT05947955
Rhu-pGSN for Acute Respiratory Distress Syndrome (ARDS)
Phase 2
Recruiting
600 enrolled
BioAegis Therapeutics Inc.
Biomedical Advanced Research and Development Authority · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
BTI-203 is a randomized, double-blind, placebo-controlled, multicenter, Phase 2 proof-of-concept (POC) study to evaluate the efficacy and safety of rhu-pGSN plus standard of care (SOC) in subjects with moderate-to-severe ARDS (P/F ratio ≤150) due to pneumonia or other infections. Potential subjects hospitalized with pneumonia or other infections are to be screened within 24 hours of diagnosis of ARDS.
Timeline
- Start
- 2024-10-03
- Primary completion
- 2026-10-01
- Completion
- 2027-03-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Rhu-pGSN | Protein / enzyme biologic | 12 mg/kg | Intravenous |