stop_circleTerminated/Withdrawn
Acute respiratory distress syndrome
Bayer Identifier:
20425
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Study to find the highest safe dose of soluble Guanylate Cyclase (sGC) Activator, BAY 1211163 administered as multiple doses by inhalation to patients who cannot breathe by their own and suffer from a type of lung failure that causes fluid to build up in the lungs making breathing difficult (ARDS)
Trial purpose
With this study researchers want to find the highest safe dose of the soluble Guanylate Cyclase (sGC) Activator, BAY 1211163 and how safe and well the study drug works. Furthermore researchers want to gather information on the way the body absorbs, distributes and gets rid of the study drug given as increasing multiple doses by inhalation to patients who cannot breathe by their own and suffer from a type of lung failure that causes fluid to build up in the lungs making breathing difficult (ARDS)
Key Participants Requirements
Sex
AllAge
18 - N/ATrial summary
Enrollment Goal
16Trial Dates
November 2020 - September 2023Phase
Phase 1Could I Receive a placebo
NoProducts
BAY1211163Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Klinikum der Stadt Köln gGmbH - Krankenhaus Merheim | Köln, 51109, Germany |
Completed | Charité - Universitätsmedizin Berlin | Berlin, 10117, Germany |
Completed | Universitätsklinikum Giessen und Marburg | Gießen, 35392, Germany |
Completed | Sana-Klinikum Remscheid|Kardio, Angio, Pneumo u. Intensivmed | Remscheid, 42859, Germany |
Withdrawn | Universitätsklinikum Essen | Essen, 45147, Germany |
Withdrawn | Universitätsklinikum Schleswig-Holstein (UKSH) | Kiel, 24105, Germany |
Primary Outcome
- Numbers of participants with treatment emergent adverse events (TEAEs)date_rangeTime Frame:Up to 9 days
- Numbers of participants with dose limiting events (DLEs)A dose limiting event is defined as any of the TEAEs occurring during dosing with BAY1211163 and regarded by the investigators to be related to BAY1211163.date_rangeTime Frame:Day 1 to 7 (may include Day 8)
Secondary Outcome
- Values of oxygenation index (OI)The Oxygenation Index (OI) is calculated by using the fraction of inspired oxygen (FiO2), the partial pressure of oxygen in arterial blood (PaO2) and the mean airway pressure (MPAW)date_rangeTime Frame:Up to 28 days
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
N/ABlinding
N/AAssignment
Single Group AssignmentTrial Arms
1