drugset / Trial / NCT03567577

Safety and Preliminary Efficacy of Sequential Multiple Ascending Doses of Solnatide to Treat Pulmonary Permeability Oedema in Patients With Moderate-to-severe ARDS

NCT03567577

Phase 2 Completed 92 enrolled Apeptico Forschung und Entwicklung GmbH
RandomizedSequentialQuadruple-blindTreatment

Summary

This phase IIb, randomized, placebo-controlled, double-blind, dose escalation study will assess the local and systemic safety of 7 days orally inhaled sequential multiple ascending doses of solnatide in patients with pulmonary permeability oedema and moderate-to-severe ARDS and review potential efficacy endpoints for a future phase III pivotal trial.

Timeline

Start
2018-05-23
Primary completion
2024-12-27
Completion
2024-12-27

Drugs

EvaluationDrugModalityDoseRoute
Subject AP301 Unknown 5 mg Inhaled
Subject AP301 Unknown 60 mg Inhaled
Subject AP301 Unknown 125 mg Inhaled