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
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|ClinicalTrials.gov Identifier: NCT04010799|
Recruitment Status : Recruiting
First Posted : July 8, 2019
Last Update Posted : July 8, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Cystic Fibrosis Non-Cystic Fibrosis Bronchiectasis||Drug: CHF 6333 Drug: Placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||48 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||
Randomised, double-blind, placebo-controlled, single-dose escalation, cross-over design in one cohort of CF patients and in one cohort of NCFB patients.
Randomised, double-blind, placebo-controlled, repeated-dose, parallel-group design in one cohort of CF patients and in one cohort of NCFB patients.
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase Ib, Randomised, Double-blind, Placebo-controlled Study to Investigate the Safety, Tolerability and Pharmacokinetics of Inhaled CHF 6333 After Single and Repeated Ascending Doses in Patients Affected by Cystic Fibrosis and Non Cystic Fibrosis Bronchiectasis|
|Actual Study Start Date :||May 27, 2019|
|Estimated Primary Completion Date :||July 2020|
|Estimated Study Completion Date :||August 2020|
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.
Drug: CHF 6333
CHF 6333 - Part I - SAD CHF 6333 - Part II - MD
Placebo Comparator: CHF6333 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
Placebo - Part I - SAD Placebo Part II - MAD
- Adverse event [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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
- QRS interval [ Time Frame: 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
- QTCf interval [ Time Frame: 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 [ Time Frame: 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
- AUC [ Time Frame: Part I: Day 1. Part II Day 1-7 ]Area under the plasma concentration curve
- Cmax [ Time Frame: Part I: Day 1. Part II Day 1-7 ]Peak plasma concentration
- T max [ Time Frame: Part I: Day 1. Part II Day 1-7 ]Time to reach the maximum plasma concentration
- C24h [ Time Frame: Part II: Day 5 Day 6 ]Trough drug concentration 24 h post dose
- Rac [ Time Frame: Part II: Day 7 ]Accumulation ratio
- NE activity [ Time Frame: Part I: Day -1 Day 1. Part II: Day -1 - 7 ]Change in neutrophil elastase activity in sputum
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04010799
|Contact: Central Contact Clinical Trial Info||0521 2791 ext +email@example.com|
|Contact: Principal Investigator +49 89893569 firstname.lastname@example.org|