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
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | AP301 | Unknown | 5 mg | Inhaled |
| Subject | AP301 | Unknown | 60 mg | Inhaled |
| Subject | AP301 | Unknown | 125 mg | Inhaled |