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
Age range
18 Years – 80 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Safety and tolerability of single ascending doses of CHF6333 in HVs and a single dose in subjects with BE (Part I), and repeated doses in subjects with BE (Part II), in terms of AEs
Timeframe: Through study completion. Part I: an average of 12 weeks and 8 weeks respectively for HVs and BE subjects. Part II: an avarage of 26 weeks
Safety and tolerability of single ascending doses of CHF6333 in HVs and a single dose in subjects with BE (Part I), and repeated doses in subjects with BE (Part II), in terms of vital signs
Timeframe: Part I:screening, day(D)-1, D1(from pre-dose until 96hrs post-dose HV, 6hrs post-dose BE), 14 to 21D post-dose.Part II:screening, D-1, D1 and 27(from pre-dose until 6hrs post-dose), D28(from pre-dose until 2hrs post-dose), 14 to 21D after last dose
heart rate (HR)
Timeframe: Part I: at day1 from pre-dose until 24hrs post-dose. Part II: at day1 and 27 from pre-dose until 8hrs post-dose
Safety and tolerability of single ascending doses of CHF6333 in HVs and a single dose in subjects with BE (Part I), and repeated doses in subjects with BE (Part II), in terms of 12-Lead ECG parameters from Holter: PR interval
Timeframe: Part I: at day1 from pre-dose until 24hrs post-dose. Part II: at day1 and 27 from pre-dose until 8hrs post-dose
Safety and tolerability of single ascending doses of CHF6333 in HVs and a single dose in subjects with BE (Part I), and repeated doses in subjects with BE (Part II), in terms of 12-Lead ECG parameters from Holter: QRS interval
Timeframe: Part I: at day1 from pre-dose until 24hrs post-dose. Part II: at day1 and 27 from pre-dose until 8hrs post-dose
Safety and tolerability of single ascending doses of CHF6333 in HVs and a single dose in subjects with BE (Part I), and repeated doses in subjects with BE (Part II), in terms of 12-Lead ECG parameters from Holter: Fridericia-corrected QT interval (QTcF)
Timeframe: Part I: at day1 from pre-dose until 24hrs post-dose. Part II: at day1 and 27 from pre-dose until 8hrs post-dose
Safety and tolerability of single ascending doses of CHF6333 in HVs and a single dose in subjects with BE (Part I), and repeated doses in subjects with BE (Part II), in terms of lung function parameters: FEV1
Timeframe: Part I: screening, day-1, day1 (from pre-dose until 24hrs post-dose for HVs and 6hrs post-dose for BE. Part II: screening, day-1, day1 and 27 (from pre-dose until 6hrs post-dose), day 28 (from pre-dose until 2hrs post-dose
Safety and tolerability of single ascending doses of CHF6333 in HVs and a single dose in subjects with BE (Part I), and repeated doses in subjects with BE (Part II), in terms of lung function parameters: FVC
Timeframe: Part I: screening, day-1, day1 (from pre-dose until 24hrs post-dose for HVs and 6hrs post-dose for BE. Part II: screening, day-1, day1 and 27 (from pre-dose until 6hrs post-dose), day 28 (from pre-dose until 2hrs post-dose
Safety and tolerability of single ascending doses of CHF6333 in HVs and a single dose in subjects with BE (Part I), and repeated doses in subjects with BE (Part II), in terms of lung function parameters: FEV1/FVC ratio
Timeframe: Part I: screening, day-1, day1 (from pre-dose until 24hrs post-dose for HVs and 6hrs post-dose for BE. Part II: screening, day-1, day1 and 27 (from pre-dose until 6hrs post-dose), day 28 (from pre-dose until 2hrs post-dose
Safety and tolerability of single ascending doses of CHF6333 in HVs and a single dose in subjects with BE (Part I), and repeated doses in subjects with BE (Part II), in terms of lung function parameters: FEV1 percentage of predicted
Timeframe: Part I: screening, day-1, day1 (from pre-dose until 24hrs post-dose for HVs and 6hrs post-dose for BE. Part II: screening, day-1, day1 and 27 (from pre-dose until 6hrs post-dose), day 28 (from pre-dose until 2hrs post-dose
Number of participants with clinical laboratory tests: Haematology
Timeframe: Part I: screening, day-1 and day5 (pre-dose) for HVs/FU for BE. Part II: screening, day-1 and 27 (pre-dose)
Number of participants with clinical laboratory tests: Biochemistry
Timeframe: Part I: screening, day-1 and day5 (pre-dose) for HVs/FU for BE. Part II: screening, day-1 and 27 (pre-dose)
Number of participants with clinical laboratory tests: Urinalysis
Timeframe: Part I: screening, day-1 and day 5 (pre-dose) for HVs/FU for BE. Part II: screening, day-1 and 27 (pre-dose)