This study evaluates the safety and tolerability of CHF10136 administered by inhalation in healthy adults and adults with asthma. The study includes single-dose, multiple-dose, and repeated-dose treatment periods and will also characterize the pharmacokinetic profile of CHF10136.
Healthy male or female participant ≥18 and ≤55 years of age
Body mass index (BMI) ≥18 and ≤30 kg/m2 at screening and weight at least 50 kg;
Good physical and mental status, determined via assessment of medical history at screening and physical examination at screening and prior to randomisation;
Spirometry measurements within normal limits at screening and prior to randomisation based on the American Thoracic Society (ATS)/European Respiratory Society (ERS) interpretative strategies for spirometry. The forced expiratory volume in the first second (FEV1) must be >80% of predicted normal value and the FEV1/Forced Vital Capacity (FVC) ratio must be >0.7.
Participation in another clinical study where investigational drug was received less than 90 days or 5 half-lives prior to screening, whichever is longer;
Clinically relevant respiratory, cardiac, hepatic, gastrointestinal, renal, endocrine, haematologic, metabolic, neurological or psychiatric disorders that may interfere with successful completion of this protocol, according to the Investigator's judgment;
Clinically relevant abnormal laboratory values at screening suggesting an unknown disease and requiring further clinical investigation or which may impact the safety of the participant or the evaluation of the results of the study, according to the Investigator's judgment.
Positive hepatitis panel and/or positive HIV test at the screening visit.
Sequential
CHF10136
DrugCHF10136 powder for inhalation administered orally using a Dry Powder Inhaler.
CHF10136 matched placebo
DrugMatching placebo powder for inhalation administered using a Dry Powder Inhaler.
Number of Participants With Treatment-Emergent Adverse Events
Assessment of safety through collection of treatment-emergent adverse events.
Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure
Change From Baseline in Electrocardiogram Parameters: HR (Heart Rate)
Change From Baseline in Electrocardiogram Parameters: Intervals recorded: PR, QT, QRS duration, QTcF (Fridericia corrected QT interval)
Area Under the Plasma Concentration-Time Curve (AUC) for CHF10136 (parent compound) and its main metabolite.)
Maximum Observed Plasma Concentration (Cmax) of CHF10136 (parent compound) and its main metabolite.)
Time to Maximum Plasma Concentration (Tmax) of CHF10136 (parent compound) and its main metabolite.)
Terminal Half-Life (t½) of CHF10136 (parent compound) and its main metabolite.)
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