Evaluation of Safety, Side Effects, and How the Drug, Inhaled CHF10136, Is Absorbed, Modified and Removed From the Body in Healthy Adults and Adults With Asthma

For PART 1 - SAD

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.

Presence of any current infection, previous infection that resolved less than 7 days prior to screening or prior to randomisation or other latent or chronic infections (e.g. recurrent sinusitis, genital or ocular herpes, urinary tract infection);

History of malignancy within 5 years of screening (non-melanoma skin cancer is permitted if adequately treated for 12 months prior to screening);

Abnormal liver enzymes at screening or prior to randomisation (alanine aminotransferase \[ALT\] or aspartate aminotransferase \[AST\] or total bilirubin: \>1.0 × upper limit of normal \[ULN\]).

Known intolerance and/or hypersensitivity to the Investigational Medicinal Product (IMP) or to any of the excipients contained in the formulation used in the study;

For females only: pregnant or lactating women, where pregnancy is defined as the state of a female after conception and until termination of the gestation.

For PART 2 - MAD

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 and uncontrolled respiratory disorders, including high-risk and non-persistent asthma; clinically relevant, uncontrolled, 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;

History of any clinically significant respiratory disorders including but not limited to chronic obstructive pulmonary disease, idiopathic pulmonary fibrosis, alpha-1 antitrypsin deficiency, bronchiectasis, sarcoidosis, pulmonary hypertension or interstitial lung disease;

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.

Presence of any current infection, previous infection that resolved less than 7 days prior to screening or prior to randomisation or other latent or chronic infections (e.g. recurrent sinusitis, genital or ocular herpes, urinary tract infection);

Lower respiratory tract infection not resolved within 8 weeks prior to screening and/or randomisation, as determined by the Investigator;

Asthma exacerbation requiring medication or visit to the emergency department, including increase in Short-Acting Beta-Agonists (SABA) use, within 8 weeks of screening or during the study;

Use of inhaled or systemic corticosteroids within 12 weeks of screening or prior to randomisation;

Use of any asthma controller medication within 4 weeks of screening or prior to randomisation (including, but not limited to, LABA, leukotriene antagonists, xanthines, anti-cholinergics);

History of malignancy within 5 years of screening (non-melanoma skin cancer is permitted if adequately treated for 12 months prior to screening);

Abnormal liver enzymes at screening or prior to randomisation (ALT or AST or total bilirubin:\>1.0 × upper limit of normal \[ULN\]).

For females only: pregnant or lactating women, where pregnancy is defined as the state of a female after conception and until termination of the gestation.

For PART 3 - REPEATED DOSE

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 and uncontrolled respiratory disorders, including high-risk and non-persistent asthma; clinically relevant, uncontrolled, 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;

History of any clinically significant respiratory disorders including but not limited to chronic obstructive pulmonary disease, idiopathic pulmonary fibrosis, alpha-1 antitrypsin deficiency, bronchiectasis, sarcoidosis, pulmonary hypertension or interstitial lung disease;

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.

Presence of any current infection, previous infection that resolved less than 7 days prior to screening or prior to randomisation or other latent or chronic infections (e.g. recurrent sinusitis, genital or ocular herpes, urinary tract infection);

Asthma exacerbation or lower respiratory tract infection requiring medication or visit to the emergency department within 4 weeks prior to screening and/or prior to randomisation;

Use of systemic corticosteroids within 8 weeks of screening or prior to randomisation;

History of malignancy within 5 years of screening;

For females only: pregnant or lactating women, where pregnancy is defined as the state of a female after conception and until termination of the gestation;

What this study is about