Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Inhaled CHF6333 in Healthy Adults and Adults With Bronchiectasis Using Single and Repeated Doses

What this Trial Is About

Researchers are evaluating the safety, tolerability, and pharmacokinetics of the inhaled study drug CHF6333 in healthy volunteers and adults with bronchiectasis. The study includes two parts Part I assesses single ascending doses in healthy volunteers and a single dose in bronchiectasis patients, while Part II evaluates repeated doses in bronchiectasis subjects. This trial is randomized, double-blind, and placebo-controlled, aiming to better understand how CHF6333 behaves and affects participants with bronchiectasis. Participants receive either CHF6333 or a matching placebo inhaled once daily. In Part I, healthy volunteers receive single ascending doses across three levels, and bronchiectasis patients receive a single dose. In Part II, bronchiectasis subjects receive repeated doses once daily for 28 consecutive days at two dose levels. The study uses a 3-way cross-over design in Part II for bronchiectasis patients to compare multiple dosing regimens. Participants will undergo thorough monitoring including vital signs, heart rate, ECG parameters, and lung function tests such as FEV1 and FVC at multiple time points before and after dosing. Blood and sputum samples will be collected for laboratory tests and pharmacokinetic analyses. Safety and tolerability will be assessed by tracking adverse events throughout the study. The total study duration varies, with Part I lasting about 8 to 12 weeks, and Part II approximately 26 weeks for bronchiectasis subjects.

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