Actively Recruiting
A Randomised, Double-blind, Placebo-controlled Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Inhaled CHF6333 After Single Ascending Doses in Healthy Volunteers and One Single Dose in Adult Subjects With Bronchiectasis, Followed by a Placebo-controlled, Repeated Dose, 3-way Cross-over in Adult Subjects With Bronchiectasis
Led by Chiesi Farmaceutici S.p.A. · Updated on 2026-03-05
45
Participants Needed
9
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and pharmacokinetics of the inhaled study drug CHF6333 in healthy volunteers and adults with bronchiectasis. The study includes two parts: Part I assesses single ascending doses in healthy volunteers and a single dose in bronchiectasis patients, while Part II evaluates repeated doses in bronchiectasis subjects. This trial is randomized, double-blind, and placebo-controlled, aiming to better understand how CHF6333 behaves and affects participants with bronchiectasis. Participants receive either CHF6333 or a matching placebo inhaled once daily. In Part I, healthy volunteers receive single ascending doses across three levels, and bronchiectasis patients receive a single dose. In Part II, bronchiectasis subjects receive repeated doses once daily for 28 consecutive days at two dose levels. The study uses a 3-way cross-over design in Part II for bronchiectasis patients to compare multiple dosing regimens. Participants will undergo thorough monitoring including vital signs, heart rate, ECG parameters, and lung function tests such as FEV1 and FVC at multiple time points before and after dosing. Blood and sputum samples will be collected for laboratory tests and pharmacokinetic analyses. Safety and tolerability will be assessed by tracking adverse events throughout the study. The total study duration varies, with Part I lasting about 8 to 12 weeks, and Part II approximately 26 weeks for bronchiectasis subjects.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent before any study procedures
- Age 18 to 60 years for healthy volunteers; age 18 to 80 years for bronchiectasis subjects
- Healthy volunteers must be in good physical and mental health with normal vital signs and lung function
- Bronchiectasis subjects must have clinical history confirmed by chest CT and stable condition with no exacerbations for 4 weeks
- Ability to correctly use inhalers and generate sufficient peak inspiratory flow of at least 40 L/min
- Male and female subjects with partners of childbearing potential must agree to use effective contraception
- Body mass index between 18 and 35 kg/m2 for healthy volunteers; BMI at least 17 kg/m2 for bronchiectasis subjects
- Non-smokers or ex-smokers with less than 5 pack-years who quit over 1 year ago for healthy volunteers; bronchiectasis subjects must have stopped smoking at least 1 year prior
- Bronchiectasis subjects with post-bronchodilator FEV1 at least 50% predicted (Part I) or 30% predicted (Part II)
- Bronchiectasis subjects, if on treatment, must be on stable doses
- Bronchiectasis subjects for Part II must produce sputum samples and have active neutrophil elastase (NE) levels
You will not qualify if you...
- Participation in another investigational drug study within 3 months (healthy volunteers) or 30 days (bronchiectasis subjects)
- Significant uncontrolled respiratory, cardiac, liver, kidney, neurological or psychiatric disorders
- Abnormal lab values or ECG that may affect safety
- History of respiratory diseases (healthy volunteers) or primary asthma diagnosis (bronchiectasis subjects)
- Positive HIV or hepatitis B or C serology
- Recent COVID-19 infection or symptoms within 2 to 4 weeks prior to screening
- Recent blood donation or blood loss within 2 months
- Pregnant or lactating women
- Use of electronic smoking devices within 6 months (healthy volunteers) or 6 months to 1 year (bronchiectasis subjects)
- Current smokers; ex-smokers must have quit at least 1 year ago
- Active infections, tuberculosis or fungal bronchopulmonary aspergillosis requiring treatment
- Use of prohibited medications or monoclonal antibodies for respiratory diseases
- History of organ transplantation or immunosuppressive therapy
- Diagnosed immunodeficiency or rheumatoid arthritis
- Malignancy not in remission for at least 1 year
- BMI less than 17 kg/m2 (bronchiectasis subjects)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 28 days
Participants receive single ascending doses of inhaled CHF6333 or placebo, followed by repeated doses for 28 consecutive days in subjects with bronchiectasis.
Multiple visits including dosing days and monitoring visits during dosing
Duration - Up to 26 weeks
Participants are monitored for safety, tolerability, pharmacokinetics, and lung function after the dosing period.
Weekly visits for up to 26 weeks
Trial Site Locations
Total: 9 locations
1
Royal Papworth Hospital NHS Foundation Trust, Cambridge Centre for Lung Infection
Cambridge, United Kingdom
Actively Recruiting
2
Tayside Medical Science Centre, Ninewells Hospital & Medical School
Dundee, United Kingdom
Actively Recruiting
3
NHS Lothian
Edinburgh, United Kingdom
Actively Recruiting
4
Glasgow Royal Infirmary
Glasgow, United Kingdom
Actively Recruiting
5
The Leeds Teaching Hospitals NHS Trust, Saint James's University Hospital
Leeds, United Kingdom
Withdrawn
6
Royal Bromptom Hospital (NHS Guy's and Thomas')
London, United Kingdom
Actively Recruiting
7
Manchester University NHS Foundation Trust
Manchester, United Kingdom
Actively Recruiting
8
Medicines Evaluation Unit (MEU)
Manchester, United Kingdom
Actively Recruiting
9
University Hospital Southampton NHS Foundation Trust
Southampton, United Kingdom
Actively Recruiting
Research Team
C
Chiesi Clinical Trial info
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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