NCT03567577

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

Safety and Preliminary Efficacy of Sequential Multiple Ascending Doses of Solnatide to Treat Pulmonary Permeability Oedema in Patients With Moderate-to-severe ARDS - a Randomised, Placebo-controlled, Double-blind Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 92 (actual)
• Sponsor: Apeptico Forschung und Entwicklung GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• ARDS

Interventions

Type	Name	Description
DRUG	Solnatide 25 mg powder for reconstitution for solution for inhalation	Inhalation of an aerosol every 12 hours (± 30 min), for a total of 7 days.
DRUG	0.9% Saline Solution	Inhalation of an aerosol every 12 hours (± 30 min), for a total of 7 days.

Timeline

• Start date: 2018-05-23
• Primary completion: 2024-12-27
• Completion: 2024-12-27
• First posted: 2018-06-26
• Last updated: 2025-05-14

Locations

15 sites across 2 countries: Austria, Germany