A Comparison Study Between Adolescents With Asthma and Adults With Asthma on How They Absorb, Metabolise and Eliminate CHF 6001

Inclusion Criteria:

1. Informed consent: subject's and/or parents or legal representative (for adolescents)written informed consent obtained prior to any study-related procedures.

2. Sex and age: a. Adolescent: male or female subjects aged ≥12 and <18 years; b.Adult: male or female subjects aged ≥18 and ≤75 years.

3. Body weight for adolescents within the range of ≥34.7 kg for 12 years old and ≥40.4kg for 13 to 17 years old.

4. Body mass index for adults within the range of ≥18.0 to ≤30.0 kg/m2.

5. Diagnosis of asthma: a documented history of physician diagnosed asthma according tointernational guidelines (GINA) update 2024 for ≥1 year, with diagnosis before theage of 50 years for adults.

6. Stable asthma therapy: a stable treatment with medium dose of inhaledcorticosteroids (ICS) (medium-dose ICS defined as beclometasone dipropionate [BDP]non-extrafine >500 to 1000 μg or estimated clinical comparable dose as per GINAguidelines update 2024) alone or in fixed combination with a Long-acting β2-agonist (LABA) with or without long-acting muscarinic antagonist (for subjects ≥18 years oldonly) for ≥3 months before screening.

7. Lung function: adolescent and adult subjects with a Forced Expiratory Volume in 1Second (FEV1) >70% of predicted values (% predicted) after withholding short-acting β2-agonist (SABA) treatment for a minimum of 6 hours before screening or 24 hours incase of ICS and LABA (alone or in fixed combination).

8. A cooperative attitude and ability: a. To correctly use the inhalers; b. To performall study-related procedures including technically acceptable spirometry accordingto the 2019 American Thoracic Society (ATS)/ European Respiratory Society (ERS)guidelines.

9. Female subjects fulfilling one of the following criteria: a. Women ofnon-childbearing potential (WONCBP) defined as physiologically incapable of becomingpregnant (i.e., postmenopausal or permanently sterile, as per definitions given inSection 1.1 of the Clinical Trials Coordination Group (CTCG) guidance). Tuballigation or partial surgical interventions are not acceptable. If indicated, as perInvestigator's request, postmenopausal status may be confirmed byfollicle-stimulating hormone levels (according to local laboratory ranges). b. Womenof childbearing potential (WOCBP) fulfilling one of the following criteria: i. WOCBPwith fertile male partners: they and/or their partner must be willing to use ahighly effective birth control method from the signature of the informed consent anduntil the follow-up (FU) visit or; ii. WOCBP with non-fertile male partners (contraception is not required in this case). For the definition of WOCBP, fertilemen and the list of highly effective birth control methods, refer to or Section 1.1and 4.1 of the CTCG guidance.

Exclusion Criteria:

1. Blood donation (≥450 mL) or blood loss, less than 2 months before screening orbefore enrolment on Day 1, applicable for adults only.

2. History of "at risk" asthma: history of near fatal asthma or of a pasthospitalisation for asthma in intensive care unit which, in the judgement of theInvestigator, may place the subject at undue risk.

3. Recent exacerbation or respiratory tract infection: hospitalisation, emergency roomadmission or use of systemic corticosteroids for an asthma exacerbation orrespiratory tract infection in the 4 weeks before the screening visit. Note:Subjects experiencing an exacerbation or respiratory tract infection during thescreening visit may be rescreened once, ≥6 weeks after recovery. If there is norecovery, such event constitutes an exclusion criterion and leads to screeningfailure.

4. Subjects using systemic corticosteroid medication 4 weeks or slow releasecorticosteroids 12 weeks before enrolment.

5. Patients being treated with anti-inflammatory asthma monoclonal antibodies orbiological drugs which can affect asthma inflammation within 6 months before or fivehalf-lives (whichever is greater) before the screening visit.

6. Respiratory disorders other than asthma: subjects with known respiratory disordersother than asthma. This can include, but is not limited to, Chronic ObstructivePulmonary Disease (COPD), α1-antitrypsin deficiency, active tuberculosis,bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitiallung disease and others.

7. Smoking status: current smoker, ex-smoker with a smoking history of ≥10 pack-years (pack-years = the number of cigarette packs per day times the number of years) orcurrent use of inhaled or oral cannabis products. Ex-smokers must have stoppedsmoking for ≥1 year (≥6 months for e-cigarettes).

8. Alcohol/drug abuse: subjects with a known or suspected history of alcohol and/ordrug abuse within 12 months before screening.

9. Cancer or history of cancer: subjects with active cancer or a history of cancer with <5 years disease free survival time (whether there is evidence of local recurrenceor metastases). Localised carcinoma (e.g., basal cell carcinoma, in situ carcinomaof the cervix adequately treated) is acceptable.

10. Cardiovascular disease: subjects who have clinically significant (CS) cardiovascularcondition according to Investigator's judgement, such as heart failure (New YorkHeart Association class >3), acute ischemic heart disease in the last year prior toscreening, history of sustained cardiac arrhythmias or sustained and non-sustainedcardiac arrhythmias diagnosed in the last 6 months prior to screening (sustainedmeans lasting >30 seconds or ending only with external action, or leads tohaemodynamic collapse; nonsustained means >3 beats <30 seconds, and/or endingspontaneously and/or asymptomatic), high degree impulse conduction blocks (>2nddegree atrioventricular block type 2). Similarly, subjects affected by persistent,long-standing or paroxysmal atrial fibrillation will not be considered forenrolment. Note: Subjects with permanent atrial fibrillation (for ≥6 months beforethe screening visit) with a resting ventricular rate <100/min, controlled with arate control strategy (i.e., selective β-blocker, calcium channel blocker, pacemakerplacement, digoxin or ablation therapy) can be considered for enrolment.

11. Electrocardiogram (ECG) criteria: an abnormal and CS 12-lead ECG that in theInvestigator's opinion would affect efficacy or safety evaluation or place thesubjects at risk. Male subjects whose 12-lead ECG shows Fridericia's Corrected QTInterval (QTcF )>450 ms or female subjects with a QTcF >460 ms (adolescent females)or >470 ms (adult females) at screening or at enrolment (criterion not applicablefor subjects with pacemaker or permanent atrial fibrillation).

12. Other severe acute or chronic medical or malignancy or psychiatric condition orlaboratory abnormality that may increase the risk associated with studyparticipation or study treatment administration or may interfere with theinterpretation of study results and, in the judgment of the Investigator, would makethe subject inappropriate for entry into this study.

13. Liver diseases: subjects with severe hepatitis, chronic active hepatitis or evidenceof uncontrolled chronic liver disease according to the Investigator's opinion.

14. Drugs with hepatoxicity potential: subjects receiving treatment with any drug knownto have a well-defined potential for hepatotoxicity (i.e., isoniazide, nimesulide,ketoconazole) and strong inhibitors of cytochrome P450 (CYP) 3A4/5 (i.e.,itraconazole) within the previous 3 months before the screening visit.

15. Subjects having received a vaccination within 2 weeks before the screening visit.

16. Subjects with major surgery in the 3 months before the screening visit or plannedsurgery during the study.

17. Subjects with a history of hypersensitivity and/or idiosyncrasy to any of the testcompounds or excipients employed in this study.

18. Subjects treated with monoamine oxidase inhibitors or tricyclic antidepressants.

19. Subjects treated with non-potassium sparing diuretics (unless administered as afixed dose combination with a potassium conserving drug or changed to potassiumsparing agent before the screening), non-selective beta blocking drugs, quinidine,quinidine-like anti-arrhythmics or any medication with a Corrected QT Interval (QTc)prolongation potential or a history of QTc prolongation.

20. Subjects who are receiving any therapy that could interfere with the studytreatments according to Investigator's opinion.

21. Subjects who have received an investigational drug within 30 days or five half-lives (whichever is greater) prior to the screening visit, or have been previouslyrandomised in this study or are currently participating in another study.

22. Documented coronavirus disease 2019 diagnosis within the last 2 weeks, or associatedcomplications or symptoms, which have not resolved within 14 days before screening.

23. For females only: pregnant or lactating women, where pregnancy is defined as thestate of a female after conception and until termination of the gestation, confirmedby a positive serum human chorionic gonadotropin laboratory test at screening visitand urine test at Day 1.