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

NCT03567577 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2025-05-14

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Apeptico Forschung und Entwicklung GmbH

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Austria
  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03567577 on ClinicalTrials.gov