A Clinical Study to Investigate Safety, Tolerability and Distribution of CHF 6333 After One or After Repeated Inhalation in Patients With Cystic Fibrosis (CF) and in Patients With Non Cystic Fibrosis (NCFB) Bronchiectasis
- Conditions
- Cystic FibrosisNon-Cystic Fibrosis Bronchiectasis
- Interventions
- Drug: Placebo
- Registration Number
- NCT04010799
- Lead Sponsor
- Chiesi Farmaceutici S.p.A.
- Brief Summary
CHF 6333 is a medicinal product on development for the treatment of cystic fibrosis and non-CF bronchiectasis and undergoing clinical testing. It has not yet been approved by the authorities for the treatment of these diseases.
CHF6333 is an inhaled anti-inflammatory which mechanism of action is based on the inhibition of Human Neutrofil Elastase.
The safety and tolerability of single and repeated ascending doses of inhaled CHF 6333 was previously investigated in healthy subjects: information was gathered on the uptake, distribution and excretion of the medicinal product being tested (pharmacokinetics). In this current clinical trial CHF 6333 will be tested in patients(CF and NCFB) for the first time.
Three dose level will be tested during the first part of the study, as single administration. One repeated dose will be administered in the second part of the study.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 68
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description CHF6333 Placebo Placebo Part I (SAD): Single dose of placebo matching CHF6333 at each period Part II (MD): Once daily multiple doses of placebo matching CHF6333 for 7 consecutive days CHF6333 CHF 6333 CHF6333 Active (part I - SAD). Once daily inhaled single dose of CHF6333 at each period (three dose level). CHF6333 Active (part II -MD). Once daily inhaled multiple dose of CHF6333 for 7 consecutive days.
- Primary Outcome Measures
Name Time Method QRS interval Part I: Day 1 pre dose up to 8 hours post dose. Part II: Day 1 and Day 7 pre dose up to 12 hours post dose Change in QRS interval
Adverse event Part I: Baseline through end of treatment (up to a maximum of 30 days after last study drug intake) ; Part II Baseline through end of treatment (up to a maximum of 30 days after last study drug intake) Occurrence and severity of adverse events
Change in Vital signs Part I: Day 1 pre-dose up to 6 hours post dose. Part II: Day 1 and Day 7 pre dose up to 6 hours post dose Change in Systolic and Diastolic blood pressure
Heart Rate Part I: Day 1 pre dose up to 8 hours post dose. Part II: Day 1 and Day 7 pre dose up to 12 hours post dose Change in Heart Rate
PR interval Part I: Day 1 pre dose up to 8 hours post dose. Part II: Day 1 and Day 7 pre dose up to 12 hours post dose Change in PR interval
QTCf interval Part I: Day 1 pre dose up to 8 hours post dose. Part II: Day 1 and Day 7 pre dose up to 12 hours post dose Change in QTCf interval
FEV1 Part I: Day 1 pre dose up to 6 hours post dose. Part II: Day 1 and Day 7 pre dose up to 6 hours post dose. Day 2 -6: pre dose up to 2 hours post dose Change in FEV1
- Secondary Outcome Measures
Name Time Method Rac Part II: Day 7 Accumulation ratio
AUC Part I: Day 1. Part II Day 1-7 Area under the plasma concentration curve
Cmax Part I: Day 1. Part II Day 1-7 Peak plasma concentration
T max Part I: Day 1. Part II Day 1-7 Time to reach the maximum plasma concentration
C24h Part II: Day 5 Day 6 Trough drug concentration 24 h post dose
NE activity Part I: Day -1 Day 1. Part II: Day -1 - 7 Change in neutrophil elastase activity in sputum
Trial Locations
- Locations (1)
IKF Institut für klinische Forschung Pneumologie
🇩🇪Frankfurt/Main, Germany