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)
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Participants will receive one of the drug doses of BAY1211163 solution three times per day (TID) by inhalation for seven days.
Universitätsklinikum Giessen und Marburg
Giessen, Hesse, Germany
Klinikum der Stadt Köln gGmbH - Krankenhaus Merheim
Cologne, North Rhine-Westphalia, Germany
Sana-Klinikum Remscheid|Kardio, Angio, Pneumo u. Intensivmed
Remscheid, North Rhine-Westphalia, Germany
Charité - Universitätsmedizin Berlin
Berlin, Germany
Numbers of participants with treatment emergent adverse events (TEAEs)
Time 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.
Time frame: Day 1 to 7 (may include Day 8)
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)
Time frame: Up to 28 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.