Actively Recruiting
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
Led by Chiesi Farmaceutici S.p.A. · Updated on 2026-03-05
45
Participants Needed
9
Research Sites
139 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official 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 obtained before any study procedures
- Healthy males or females aged 18 to 60 years (for healthy volunteers)
- Ability to understand study procedures and use inhalers correctly with peak inspiratory flow (PIF) at least 40 L/min
- Body mass index (BMI) between 18 and 35 kg/m2
- Non-smokers or ex-smokers with less than 5 pack-years who quit over 1 year ago
- Good physical and mental health with normal vital signs and lung function at screening
- Male subjects willing to use condoms if partners are women of childbearing potential; female subjects and partners willing to use highly effective birth control if applicable
- Adults aged 18 to 80 years with bronchiectasis confirmed by chest CT scan affecting one or more lobes
- Post-bronchodilator FEV1 of at least 50% predicted (Part I) or at least 30% predicted (Part II) at screening
- Stable bronchiectasis treatment if applicable, with no exacerbation for at least 4 weeks before randomization
- Ability to understand study and use inhalers correctly with PIF at least 40 L/min
- Male and female contraception requirements same as healthy volunteers
- For Part II: regular daily sputum producers able to provide sputum samples and with active neutrophil elastase level in sputum
You will not qualify if you...
- Participation in another clinical study with investigational drug within 3 months prior to randomization
- Uncontrolled respiratory, cardiac, hepatic, gastrointestinal, renal, endocrine, hematologic, metabolic, neurological, or psychiatric disorders
- Abnormal laboratory values suggesting unknown disease or impacting safety
- History of respiratory diseases (for healthy volunteers)
- Positive HIV1 or HIV2 serology
- Acute or chronic hepatitis B or C infection
- Recent COVID-19 diagnosis or symptoms unresolved within 2 weeks (healthy volunteers) or 4 weeks (bronchiectasis subjects)
- Recent blood donation or blood loss
- Abnormal liver enzymes
- Positive urine cotinine test
- History of alcohol or drug abuse within 12 months
- Use of prohibited medications during the study
- Current infection or infection resolved less than 7 days prior to screening
- Known intolerance or hypersensitivity to study drug excipients
- Unsuitable veins for repeated blood draws
- Heavy caffeine consumption
- Pregnancy or lactation (females)
- Use of electronic smoking devices within 6 months prior to screening (healthy volunteers)
- Unstable or uncontrolled chronic comorbidities
- Acute respiratory tract infection within 4 weeks prior to randomization
- Abnormal clinically significant ECG findings
- Primary asthma diagnosis
- Diagnosis of cystic fibrosis
- COPD with airflow obstruction and significant smoking history
- Current smokers or recent ex-smokers
- Active mycobacterial infections or allergic bronchopulmonary aspergillosis requiring treatment
- Immunodeficiencies requiring immunoglobulin treatment
- Rheumatoid arthritis
- Recent malignancy or untreated carcinomas
- History of organ transplantation with immunosuppression
- Use of antimicrobials within 4 weeks prior to randomization except stable macrolides
- History of bronchospasm or intolerance to inhaled therapy
- Alpha-1-antitrypsin deficiency
- Use of monoclonal antibodies for respiratory conditions
- Presence of traction bronchiectasis
- BMI less than 17 kg/m2
- Use of oral or inhaled antibiotics as chronic treatment less than 3 months prior to randomization (Part II)
AI-Screening
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Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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