Study to Assess the Effect of the New HFA-152a Propellant on Mucociliary Clearance

Inclusion Criteria

• Subject's written informed consent obtained prior to any study-related procedure;
• Healthy male and female subjects aged 18-55 years (inclusive);
• Ability to understand the study procedures, the risks involved and ability to be trained to use the inhalers correctly;
• Body Mass Index (BMI) between 18 and 30 kg/m2 (extremes inclusive);
• Non-smokers or ex-smokers who smoked 5 years prior to screening;
• Good physical and mental status at screening and before randomisation;
• Vital signs within normal limits at screening; body temperature < 37.5°C;
• 12-lead digitised electrocardiogram (ECG) in triplicate considered as normal at screening;
• Lung function measurements within normal limits at screening;
• Female subjects fulfilling one of the following criteria: Women of non-childbearing potential (WONCBP). Women of childbearing potential (WOCBP) with fertile male partners: they and/or their partner must be willing to use a highly effective birth control method preferably with low user dependency, from the signature of the informed consent form (ICF) and until the follow-up call.
• Male subjects fulfilling one of the following criteria: Fertile male subjects with a pregnant or non-pregnant WOCBP partner: they must be willing to use male condom, from the signature of the ICF until the follow-up call.

Exclusion Criteria

• Participation in another clinical study with an investigational drug in the 3 months or five half-lives of that investigational drug (whichever is longer) preceding the administration of the study treatment;
• Clinically relevant and uncontrolled respiratory, cardiac, hepatic, gastrointestinal, renal, endocrine, metabolic, neurologic, or psychiatric disorders ;
• Clinically relevant abnormal laboratory values at screening;
• Subjects with history of breathing problems (i.e. history of asthma including childhood asthma);
• Positive serology test for human immunodeficiency virus (HIV) 1 or HIV2 serology at screening;
• Positive results from the hepatitis serology, indicating acute or chronic hepatitis B or hepatitis C at screening;
• Blood donation or blood loss (≥ 450 mL) during the 2 months prior to screening or randomisation;
• Positive urine test for cotinine at screening or prior to randomisation;
• Documented history of alcohol abuse within 12 months prior to screening, an average weekly alcohol intake of greater than 14 units, or a positive alcohol breath test at screening or prior to randomisation;
• Documented history of drug abuse within 12 months prior to screening or a positive urine drug screen evaluated at screening or prior to randomisation;
• Intake of non-permitted concomitant medications in the predefined period prior to screening or prior to randomisation;
• Presence of any current infection, or previous infection that resolved less than 1 week prior to screening or to randomisation;
• Known intolerance and/or hypersensitivity to any of the excipients contained in the formulation used in the study;
• Documented coronavirus disease 2019 (COVID-19) diagnosis within the last 2 weeks, or associated complications/symptoms which have not resolved within 2 weeks prior to screening or prior to randomisation;
• Heavy caffeine drinker;
• For females only: pregnant or lactating women;
• The use of any kind of smoking electronic devices (e.g. e-cigarettes), within 6 months before screening or prior to randomisation;
• Subjects for whom participation in this study will exceed a total radiation exposure of 5 mSv in the last 12-month period or 10 mSv in the last 5-year period;
• Subjects with a total dosimetry value (including history of exposure through occupation) which contraindicates their participation in the study.