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

This study evaluates the safety and tolerability of CHF10136 administered by inhalation in healthy adults and adults with asthma. The study includes single-dose, multiple-dose, and repeated-dose treatment periods and will also characterize the pharmacokinetic profile of CHF10136.

• 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…

Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.