drugset / Trial / NCT05947955

Rhu-pGSN for Acute Respiratory Distress Syndrome (ARDS)

NCT05947955 ↗

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

EvaluationDrugModalityDoseRoute
Subject Rhu-pGSN Protein / enzyme biologic 12 mg/kg Intravenous