Phase 1a1b Study Evaluating Safety and Effects of Inhaled Rev-56 in Healthy Adults and Adults with Non-cystic Fibrosis Bronchiectasis with Chronic Pseudomonas Aeruginosa

What this Trial Is About

Researchers are evaluating inhaled Rev-56 in a Phase 1a1b study to assess its safety, tolerability, microbiological response, and how the body processes this treatment. The study involves adult healthy volunteers and adults with non-cystic fibrosis bronchiectasis NCFB who have chronic Pseudomonas aeruginosa infection. The study is designed to compare Rev-56 with a placebo, aiming to gain early information about its effects and safety. The study has two parts. Phase 1a Part A tests single doses of inhaled Rev-56 at increasing amounts in healthy adults, with participants randomly assigned to receive either the treatment or placebo. Phase 1b Part B involves adults with NCFB and evaluates multiple doses given once or twice daily for seven days, again comparing Rev-56 to placebo. The treatment is delivered by inhalation using a special nebulizer device. Different dose levels are studied to understand how the treatment behaves in the body and its impact on lung infection. Participants will undergo various assessments including monitoring for side effects, lab tests, lung function tests, and heart monitoring over 21 days for healthy volunteers and 28 days for NCFB patients. Blood samples will be taken at specified times to measure how much Rev-56 is in the body. In NCFB patients, sputum samples will be collected to measure bacteria levels. The study focuses on safety outcomes and changes in lung infection to help guide future research. Participation may last up to about one month depending on the group.

A Phase 1a/1b Study to Investigate the Safety, Tolerability, Microbiological Response, and Pharmacokinetics of Inhaled Rev-56 in Adult Healthy Volunteers and Adult Non-cystic Fibrosis Bronchiectasis (NCFB) Patients With Chronic P. Aeruginosa