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

Ki vehet részt

• For PART 1 - SAD
• Healthy male or female participant ≥18 and ≤55 years of age
• Body mass index (BMI) ≥18 and ≤30 kg/m2 at screening and weight at least 50 kg
• Good physical and mental status, determined via assessment of medical history at screening and physical examination at screening and prior to randomisation
• Spirometry measurements within normal limits at screening and prior to randomisation based on the American Thoracic Society (ATS)/European Respiratory Society (ERS) interpretative strategies for spirometry. The forced expiratory volume in the first second (FEV1) must be >80% of predicted normal value and the FEV1/Forced Vital Capacity (FVC) ratio must be >0.7
• Male and Female participants willing and able to comply with study procedures; For PART 2 - MAD
• Male or female participants ≥18 and ≤55 years of age at screening
• BMI ≥18 and ≤32 kg/m2 at screening and weight at least 50 kg
• Physician-diagnosed asthma for at least 6 months and before the age of 50 years. Documented evidence of one of the confirmed variable expiratory airflow criteria, as per the GINA 2026 guidelines, is required within 10 years prior to screening
• Not currently receiving regular maintenance therapy for asthma, with no changes to treatment within <4 weeks prior to screening, and no exposure to ICS in the 12 weeks prior to screening including ICS reliever therapy
• Pre-bronchodilator FEV1 ≥70% of predicted at the screening visit and prior to randomisation
• Male and Female participants willing and able to comply with study procedures; For PART 3 - REPEATED DOSE
• Male or female participants ≥18 and ≤65 years of age at screening
• BMI ≥18 and ≤35 kg/m2 at screening and weight at least 50 kg
• Physician-diagnosed asthma for at least 6 months and before the age of 50 years. Documented evidence of one of the confirmed variable expiratory airflow criteria, as per the GINA 2026 guidelines, is required within 10 years prior to screening
• On a stable asthma treatment regimen of medium to high dose Inhaled Corticosteroids/Long-Acting Beta2-Agonists(ICS/LABA) (as defined by GINA 2026 guidelines) with no changes to treatment within 12 weeks prior to screening
• Pre-bronchodilator FEV1 ≥40% and ≤90% of predicted at the screening visit and prior to randomisation
• Asthma Control Questionnaire - 6 Items (ACQ-6) score of 0.5 to 3.0 at screening and prior to randomisation
• Male and Female participants willing and able to comply with study procedures

Ki nem vehet részt

• Participation in another clinical study where investigational drug was received less than 90 days or 5 half-lives prior to screening, whichever is longer
• 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)
• Participation in another clinical study where investigational drug was received less than 90 days or 5 half-lives prior to screening, whichever is longer
• 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)
• Participation in another clinical study where investigational drug was received less than 90 days or 5 half-lives prior to screening, whichever is longer
• 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
• 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
• Positive hepatitis panel and/or positive HIV test at the screening visit
• History of malignancy within 5 years of screening (non-melanoma skin cancer is permitted if adequately treated for 12 months prior to screening)
• 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
• 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
• Positive hepatitis panel and/or positive HIV test at the screening visit
• History of malignancy within 5 years of screening (non-melanoma skin cancer is permitted if adequately treated for 12 months prior to screening)
• 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
• Positive hepatitis panel and/or positive HIV test at the screening visit
• History of malignancy within 5 years of screening
• 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
• 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])
• 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
• Abnormal liver enzymes at screening or prior to randomisation (ALT or AST or total bilirubin:>1.0 × upper limit of normal [ULN])
• 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
• For PART 1 - SAD
• 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
• 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
• 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