This trial evaluates the safety and tolerability of adaptive escalating multiple doses (three times daily) of a soluble Guanylate Cyclase (sGC) Activator Inhale, as inhalation in intubated and mechanically ventilated adult patients with moderate and severe Acute Respiratory Distress Syndrome (ARDS). It is a pilot (phase Ib), first in patient, open label study which aims to test escalating multiple doses of BAY 1211163 for safety, tolerability, pharmacokinetics (PK) and PD. The first dose group will start with 400 μg. Based on the occurrence of predefined dose limiting events (DLE) the next dose group can be either escalated, de-escalated or maintained. Planned dose groups are 200 μg, 400 μg, 800 μg, 1600n μg and 3200 μg inhaled TID for 7 days. Patients will be followed up until Day 28.
