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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-005552-94 | EudraCT Number |
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Human Neutrophil Elastase (HNE) plays a pivotal role in innate immunity and in neutrophilic lung inflammation that characterized many diseases. CHF 6333 is a potent and 24h-durable inhibitor of HNE, developed as Dry Powder Inhaler (DPI) formulation. This study is designed to investigate the tolerability, safety and pharmacokinetics of inhaled CHF6333 DPI in healthy male subjects.
The study will comprise two parts:
Part 1 will consist of two alternated cohorts of healthy male subjects to assess the safety, tolerability and pharmacokinetics of Single Ascending Dose (SAD) of CHF6333.
Part 2 will consist of four sequential cohorts of healthy male subjects to assess the safety, tolerability and pharmacokinetics of Multiple Ascending Dose (MAD) of CHF6333
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CHF6333 Active | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CHF6333 (Part 1 - SAD) | Drug | Single doses of CHF6333 at each period |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Treatment-related Adverse events | Part 1 from Day 1 to 5, Part 2 from Day 1 to 15 |
| Change in Vital signs | Blood pressure | Part 1 from Day 1 to 5, Part 2 from Day 1 to 15 |
| Heart Rate | Change in Heart Rate (from ECG) | Part 1 Day 1-2, Part 2 Day 1-2 and Day 14-15 |
| QTcF interval | Change in QTcF interval (from ECG) | Part 1 Day 1-2, Part 2 Day 1-2 and Day 14-15 |
| PR interval | Change in PR interval (from ECG) | Part 1 Day 1-2, Part 2 Day 1-2 and Day 14-15 |
| QRS interval | Change in QRS interval (from ECG) | Part 1 Day 1-2, Part 2 Day 1-2 and Day 14-15 |
| Holter recording abnormalities | 24h-holter ECG recording | Part 1 Day 1-2, Part 2 Day 1-2 and Day 14-15 |
| FEV1 | Change in FEV1 (Forced exhalation volume in the first second) | Part 1 Day 1-2, Part 2 Day 1-14-15 |
| Clinical chemistry and haematology |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration | Part 1 from Day 1 to 5, Part 2 from Day 1-2 and Day 14-15 | |
| Peak plasma concentration (Cmax) | maximum plasma concentration of CHF6333 | Part 1 from Day 1 to 5, Part 2 from Day 1-2 and Day 14-15 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frédéric Vanhoutte | SGS Life Sciences, a division of SGS Belgium NV | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SGS Life Sciences | Antwerp | 2060 | Belgium |
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Part 1: alternating cross-over design
Part 2: parallel design
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| Placebo (Part 1 - SAD) |
| Drug |
Single doses of placebo matching CHF6333 at each period |
|
| CHF6333 (Part 2 - MAD) | Drug | once daily multiple doses of CHF6333 for 14 days |
|
| Placebo (Part 2 - MAD) | Drug | once daily multiple doses of placebo matching CHF6333 for 14 days |
|
change in Clinical chemistry and haematology parameters |
| Part 1 Day 1-5, Part 2 Day 1-15 |
| Urinalysis | Change in urinalysis parameters | Part 1 Day 1-5, Part 2 Day 1-15 |
| Time to reach the maximum plasma concentration (tmax) | Part 1 from Day 1 to 5, Part 2 from Day 1-2 and Day 14-15 |
| Elimination half-life (t1/2) | Part 1 from Day 1 to 5, Part 2 from Day 1-2 and Day 14-15 |
| Clearance (CL/F) | Absolute plasma clearance | Part 1 from Day 1 to 5, Part 2 from Day 1-2 and Day 14-15 |
| Volume of distribution (Vz/F) | plasma volume of distribution | Part 1 from Day 1 to 5, Part 2 from Day 1-2 and Day 14-15 |
| Urinary excretion (Ae) | Amount of CHF6333 excreted in urine | Part 1 from Day 1 to 5, Part 2 from Day 1-2 and Day 14-15 |
| fraction excreted (fe) | Percentage of drug excreted in urine | Part 1 from Day 1 to 5, Part 2 from Day 1-2 and Day 14-15 |
| Renal clearance (CLr) | Part 1 from Day 1 to 5, Part 2 from Day 1-2 and Day 14-15 |
| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
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