About this trial
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
Eligibility criteria
Qualifiers
Signed and dated informed consent obtained prior to any study-related procedure;
Healthy male or female subject ≥18 and ≤60 years of age at screening;
Ability to understand the study procedures and the risks involved, and to be trained to use inhalers correctly and to generate sufficient peak inspiratory flow (PIF) (at least 40 L/min) using the In-Check Dial set as per "GenuAir" inhaler resistance, at screening;
Body mass index (BMI) ≥18 and ≤35 kg/m2 at screening;
Disqualifiers
Participation in another clinical study where investigational drug was received and the last investigations were performed less than 3 months prior to randomisation;
Clinically relevant and uncontrolled respiratory, cardiac, hepatic, gastrointestinal, renal, endocrine, hematologic, metabolic, neurological, or psychiatric disorders that may interfere with successful completion of this protocol, according to the investigator's judgment;
Clinically relevant abnormal laboratory values at screening suggesting an unknown disease and requiring further clinical investigation or which may impact the safety of the subject or the evaluation of the results of the study, according to the investigator's judgment;
History of respiratory diseases;
Trial design
Treatments tested in this trial
- CHF6333
- CHF6333 Placebo