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

To join this study, whether you are a healthy volunteer or someone with bronchiectasis, you must be between 18 and 80 years old. If you're a healthy volunteer, you'll generally need to be in good overall health, weigh a healthy amount for your height, and have never smoked or quit smoking a long time ago. Your heart, lungs, and other body systems should be working well.

For everyone, it's important that you can understand the study information and are able to use an inhaler correctly. You'll also need to follow specific instructions about contraception during the study. If you're a woman who could become pregnant, or a man with a female partner who could become pregnant, you'll need to use reliable birth control methods.

There are also reasons why you might not be able to join. For example, if you've recently taken part in another clinical trial, have certain health conditions that aren't part of this study, or are taking medications that could interfere with the study drug, you might not be suitable. The study team will carefully check all these details to make sure it's safe for you to take part.

If you decide to take part in this study, you would first have a screening visit where doctors would check your health to make sure you're suitable. This would involve medical checks, blood tests, and lung function tests. If you qualify, you would then be given either the study medicine (CHF6333) or a dummy inhaler (placebo), which looks identical but contains no active drug. You wouldn't know which one you're getting.

For healthy volunteers, you would likely receive a single dose of the inhaler and have several check-ups afterwards to see how your body reacts. For people with bronchiectasis, the first part of the study also involves a single dose. In the second part, you would use the inhaler regularly for a set period, and there would be follow-up visits to monitor your health, take more blood samples, and perform further lung function tests. The total duration of your involvement, including all visits and follow-ups, would be explained fully by the study team.