Effect of Cyclosporine Drug Interaction on the Absorption, Metabolism and Elimination of CHF6001 in Healthy Volunteers. Drug-Drug Interaction 2 (DDI2) Study

Inclusion Criteria:

1. Subject's written informed consent obtained prior to any study related procedures;

2. Healthy male and female subjects aged 18 55 years inclusive;

3. Ability to understand the study procedures, the risks involved and ability to betrained to use the inhalers correctly and to generate sufficient peak inspiratoryflow;

4. Body mass index between 18.0 and 30.0 kg/m2 extremes inclusive;

5. Non- or ex smokers who smoked <5 pack years;

6. Good physical and mental status determined based on the medical history and ageneral clinical examination, at the Screening Visit and prior to the first dosing;

7. Vital signs within normal limits at the Screening Visit;

8. A 12-lead digitalised electrocardiogram (12-lead ECG) in triplicate considered asnormal at the Screening Visit;)

9. Pulmonary function test within normal limits at the Screening Visit;

10. Males fulfilling one of the following criteria:

11. Males with pregnant or non-pregnant women of childbearing potential (WOCBP)partners: They must be willing to use male condom from the signature of theinformed consent and until the Follow up Call; or

12. Non fertile male subjects: Contraception is not required in this case; or

13. Males with women of non childbearing potential (WONCBP) partners: Contraceptionis not required in this case;

14. Females fulfilling one of the following criteria:

15. WONCBP defined as physiologically incapable of becoming pregnant. Tuballigation or partial surgical interventions are not acceptable. If indicated, asper Investigator's request, post menopausal status may be confirmed by folliclestimulating hormone levels;

16. WOCBP fulfilling one of the following criteria: i. WOCBP with fertile malepartners: They and/or their partner must be willing to use a highly effectivebirth control method preferably with low user dependency from the signature ofthe informed consent and until the Follow up Call; or ii. WOCBP with nonfertile male partners: Contraception is not required in this case.

Exclusion Criteria:

1. Participation in another clinical study less than 8 weeks prior to the ScreeningVisit;

2. Clinically relevant and uncontrolled respiratory, cardiac, hepatic,gastrointestinal, renal, endocrine, metabolic, neurologic or psychiatric disorders,gastric surgery recently or in the past, and/or impaired gastric motility that mayinterfere with successful completion of this protocol according to theInvestigator's judgment;

3. Clinically relevant abnormal laboratory values at the Screening Visit suggesting anunknown disease and requiring further clinical investigation, or which may impactthe safety of the subject or the evaluation of the results of the study according tothe Investigator's judgment.

4. Abnormal liver enzymes at the Screening Visit (alanine aminotransferase or aspartateaminotransferase >1.5x upper limit of normal [ULN], bilirubin >1.5x ULN).

5. Subjects with history of breathing problems (e.g. history of asthma). Allergicasthma diagnosis in childhood (until 12 years old) is allowed;

6. Positive human immunodeficiency virus (HIV) 1 or HIV2 serology at the ScreeningVisit;

7. Positive results from the hepatitis serology which indicates acute or chronichepatitis B (HB) or hepatitis C (HC) at the Screening Visit;

8. Blood donation or blood loss (≥450 mL) less than 8 weeks prior to the ScreeningVisit (evaluated at the Screening Visit and before the first dosing);

9. Positive urine test for cotinine at the Screening Visit and/or prior to the firstdosing;

10. Documented history of alcohol abuse within 12 months prior to the Screening Visit ora positive alcohol breath test at the Screening Visit and/or prior to the firstdosing;

11. Documented history of drug abuse within 12 months prior to the Screening Visit or apositive urine drug screen evaluated at the Screening Visit and/or prior to thefirst dosing;

12. Presence of any current infection, or previous infection that resolved less than 7days prior to the Screening Visit and prior to the first dosing.

13. Known intolerance and/or hypersensitivity to any of the excipients contained in theformulation used in the study;

14. Unsuitable arm veins for repeated venipuncture;

15. Heavy caffeine drinker (>5 cups or glasses of caffeinated beverages, e.g. coffee,tea, cola per day);

16. For females only: Pregnant or lactating women;

17. Subjects using e-cigarettes within 6 months before the Screening Visit;

18. Positive test for coronavirus disease 2019 (antibody test or nucleic acid test)within 14 days prior to the Screening Visit and the associatedcomplications/symptoms, which have not resolved within 14 days prior to theScreening Visit;

19. Intake of non-permitted concomitant medications in the predefined period prior toscreening.