Safety and Tolerability Study of AchromoPhage Treatment for Adults with Cystic Fibrosis and Chronic Achromobacter Lung Infection

What this Trial Is About

Researchers are evaluating the safety and tolerability of AchromoPhage, a new treatment made from a mixture of four natural viruses called bacteriophages, in adults with cystic fibrosis who have long-term lung infections caused by Achromobacter bacteria. This Phase 1 study aims to understand if AchromoPhage is safe and well tolerated while also exploring its effects on lung function, quality of life, and bacterial populations in the lungs. Participants will be randomly assigned to one of three groups to receive AchromoPhage either by inhalation only, intravenous infusion only, or a combination of inhalation followed by intravenous infusion during the same visit. Each participant will receive three weekly doses with increasing amounts of the bacteriophage cocktail. The combination group receives both inhaled and intravenous doses sequentially with a 60-minute gap between. Throughout the study, participants will attend clinic visits to receive dosing over three weeks. They will provide blood, sputum, nasal, and oral samples to help researchers measure how the phages move through the body, how long they stay, and whether the body develops an immune response. Breathing tests and quality-of-life questionnaires will also be completed. The main focus is on any serious or treatment-limiting side effects during the first 42 days after dosing, along with monitoring changes in lung function, quality of life, and bacterial levels.

Bacteriophages for Adults With Cystic Fibrosis and Chronic Achromobacter Lung Infection