A Study to Investigate the Safety, Tolerability and Pharmacokinetics of Inhaled CHF10073 After Single and Multiple Doses in Healthy Volunteers and the Effect of Itraconazole on CHF10073 Exposure

Inclusion criteria

• Subject's written informed consent;
• Healthy male (Part 1 to 4) or female (Part 4) 18-55 years;
• Understanding of the study procedures and the correct use of the inhalers;
• BMI between 18.5 and 30.0 kg/m2;
• Non- or ex-smokers (<5 pack-years and stopped smoking >1 year prior to screening);
• Good physical and mental status;
• Vital signs within normal limits; body temperature <37.5°C;
• 12-lead digitised ECG in triplicate considered as normal;
• Lung function measurements within normal limits;
• Males with pregnant or non-pregnant women of childbearing potential (WOCBP) partners must be willing to use contraception
• Part 4 only: women of non-childbearing potential (WONCBP) or WOCBP with fertile male parters willing to use contraception

Exclusion criteria

• Recent participation in another clinical trial;
• Clinically significant abnormal 24h Holter ECG (Part 1 and 2);
• Clinically relevant and uncontrolled medical disorders ;
• Subjects with history of respiratory diseases ;
• Presence of any current or recent infection;
• Clinically relevant abnormal laboratory values;
• Abnormal liver enzymes;
• Positive results from the Hepatitis serology results;
• Positive HIV-1 or HIV-2 serology results ;
• Recent blood donation or blood loss (≥450 mL) ;
• Heavy caffeine drinker ;
• Recent use of any kind of electronic smoking devices;
• Documented history of alcohol abuse within 12 months prior to screening ;
• Documented history of drug abuse within 12 months prior to screening ;
• Intake of non-permitted concomitant medications ;
• Known intolerance and/or hypersensitivity to any of the study excipients ;
• Unsuitable veins for repeated venipuncture;
• Part 3 only: contraindication to the BAL procedure;
• Part 3 only: recent lower respiratory tract infections
• Part 4 only: known allergy to antifungal medicines;
• Part 4 and females only: pregnant or lactating women