This clinical trial is a single centre Phase I study, with a single dose, non-randomized, open-label, uncontrolled design.~A total of 8 subjects will be included in the study.~It will aim to assess the absolute bioavailability, the mass balance and routes of elimination of CHF6001 in male healthy volunteers, using [14C]-radiolabelled drug substance administered as an intravenous (IV) infusion concomitantly to an inhaled non-radiolabelled dose.~Standard safety assessments will be conducted during the Study, including safety blood and urine laboratory tests, vital signs, physical examinations, ECGs and observations of any adverse events. Blood, urine and feces samples will be also collected for PK analysis.
The objective of the proposed study is to evaluate the bioavailability of CHF6001 after inhaled administration and to characterize the mass balance and route of elimination of CHF6001 in human along with its relevant metabolites.