A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Inhaled CHF6333 After Single Doses in Healthy Volunteers and After Single and Repeated Doses in Subjects With Bronchiectasis
Trial Parameters
Brief Summary
The aim of this clinical trial is to assess the safety of: * single doses of the study drug CHF6333 in Healthy Volunteers (HVs) and in subjects with Bronchiectasis (BE) - Part I * repeated doses of the study drug CHF6333 in subjects with BE - Part II
Eligibility Criteria
HV Inclusion Criteria: 1. Signed and dated informed consent obtained prior to any study-related procedure; 2. Healthy male or female subject ≥18 and ≤60 years of age at screening; 3. Ability to understand the study procedures and the risks involved, and to be trained to use inhalers correctly and to generate sufficient peak inspiratory flow (PIF) (at least 40 L/min) using the In-Check Dial set as per "GenuAir" inhaler resistance, at screening; 4. Body mass index (BMI) ≥18 and ≤35 kg/m2 at screening; 5. Non-smokers or ex-smokers who smoked \<5 pack-years and stopped smoking \>1 year prior to screening; 6. Good physical and mental status, determined via assessment of medical history and clinical examination, at screening and prior to randomisation; 7. Vital signs within normal limits at screening and prior to randomisation: diastolic blood pressure (DBP) ≥40 and ≤89 mmHg, and systolic blood pressure (SBP) ≥90 and ≤139 mmHg; body temperature \<37.5°C; 8. Triplicate 12-lead electrocardiogr