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A Study to Investigate Safety, Tolerability and Pharmacokinetics of Single and Repeat Doses of CHF6333 in Healthy Subjects (CHF6333 FIH)

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ClinicalTrials.gov Identifier: NCT03056326
Recruitment Status : Completed
First Posted : February 17, 2017
Last Update Posted : November 7, 2017
Sponsor:
Information provided by (Responsible Party):
Chiesi Farmaceutici S.p.A.

Study Description
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Brief Summary:

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


Condition or disease Intervention/treatment Phase
Non-Cystic Fibrosis Bronchiectasis Cystic Fibrosis Drug: CHF6333 (Part 1 - SAD) Drug: Placebo (Part 1 - SAD) Drug: CHF6333 (Part 2 - MAD) Drug: Placebo (Part 2 - MAD) Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model Description:

Part 1: alternating cross-over design

Part 2: parallel design
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase I, Randomised, Double-blind, Placebo-controlled Study to Investigate the Safety, Tolerability and Pharmacokinetics of Inhaled CHF 6333 After Single and Repeated Ascending Doses in Healthy Male Subjects
Study Start Date : November 2016
Actual Primary Completion Date : July 2017
Actual Study Completion Date : July 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: CHF6333 Active Drug: CHF6333 (Part 1 - SAD)
Single doses of CHF6333 at each period

Drug: CHF6333 (Part 2 - MAD)
once daily multiple doses of CHF6333 for 14 days
Placebo Comparator: Placebo Drug: Placebo (Part 1 - SAD)
Single doses of placebo matching CHF6333 at each period

Drug: Placebo (Part 2 - MAD)
once daily multiple doses of placebo matching CHF6333 for 14 days


Outcome Measures
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Primary Outcome Measures :
  1. Adverse events [ Time Frame: Part 1 from Day 1 to 5, Part 2 from Day 1 to 15 ]
    Treatment-related Adverse events

  2. Change in Vital signs [ Time Frame: Part 1 from Day 1 to 5, Part 2 from Day 1 to 15 ]
    Blood pressure

  3. Heart Rate [ Time Frame: Part 1 Day 1-2, Part 2 Day 1-2 and Day 14-15 ]
    Change in Heart Rate (from ECG)

  4. QTcF interval [ Time Frame: Part 1 Day 1-2, Part 2 Day 1-2 and Day 14-15 ]
    Change in QTcF interval (from ECG)

  5. PR interval [ Time Frame: Part 1 Day 1-2, Part 2 Day 1-2 and Day 14-15 ]
    Change in PR interval (from ECG)

  6. QRS interval [ Time Frame: Part 1 Day 1-2, Part 2 Day 1-2 and Day 14-15 ]
    Change in QRS interval (from ECG)

  7. Holter recording abnormalities [ Time Frame: Part 1 Day 1-2, Part 2 Day 1-2 and Day 14-15 ]
    24h-holter ECG recording

  8. FEV1 [ Time Frame: Part 1 Day 1-2, Part 2 Day 1-14-15 ]
    Change in FEV1 (Forced exhalation volume in the first second)

  9. Clinical chemistry and haematology [ Time Frame: Part 1 Day 1-5, Part 2 Day 1-15 ]
    change in Clinical chemistry and haematology parameters

  10. Urinalysis [ Time Frame: Part 1 Day 1-5, Part 2 Day 1-15 ]
    Change in urinalysis parameters


Secondary Outcome Measures :
  1. Area under the plasma concentration [ Time Frame: Part 1 from Day 1 to 5, Part 2 from Day 1-2 and Day 14-15 ]
  2. Peak plasma concentration (Cmax) [ Time Frame: Part 1 from Day 1 to 5, Part 2 from Day 1-2 and Day 14-15 ]
    maximum plasma concentration of CHF6333

  3. Time to reach the maximum plasma concentration (tmax) [ Time Frame: Part 1 from Day 1 to 5, Part 2 from Day 1-2 and Day 14-15 ]
  4. Elimination half-life (t1/2) [ Time Frame: Part 1 from Day 1 to 5, Part 2 from Day 1-2 and Day 14-15 ]
  5. Clearance (CL/F) [ Time Frame: Part 1 from Day 1 to 5, Part 2 from Day 1-2 and Day 14-15 ]
    Absolute plasma clearance

  6. Volume of distribution (Vz/F) [ Time Frame: Part 1 from Day 1 to 5, Part 2 from Day 1-2 and Day 14-15 ]
    plasma volume of distribution

  7. Urinary excretion (Ae) [ Time Frame: Part 1 from Day 1 to 5, Part 2 from Day 1-2 and Day 14-15 ]
    Amount of CHF6333 excreted in urine

  8. fraction excreted (fe) [ Time Frame: Part 1 from Day 1 to 5, Part 2 from Day 1-2 and Day 14-15 ]
    Percentage of drug excreted in urine

  9. Renal clearance (CLr) [ Time Frame: Part 1 from Day 1 to 5, Part 2 from Day 1-2 and Day 14-15 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male subjects aged 18-55 years
  • BMI between 18-30 kg/m2
  • Non smokers
  • Lung function above 80% of predicted normal value
  • Healthy subjects based on medical evaluation including medical history, physical examination, laboratory tests and cardiac testing

Exclusion Criteria:

  • Any clinically relevant abnormalities and/or uncontrolled diseases
  • Abnormal laboratory values
  • Recent respiratory tract infection
  • Hypersensitivity to the drug or excipients
  • Positive serology results
  • Positive cotinine, alcohol, drug of abuse tests
  • Unsuitable veins for repeated venepuncture
Contacts and Locations
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Information from the National Library of Medicine

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): NCT03056326


Locations
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Belgium
SGS Life Sciences
Antwerpen, Belgium, 2060
Sponsors and Collaborators
Chiesi Farmaceutici S.p.A.
Investigators
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Principal Investigator: Frédéric Vanhoutte SGS Life Sciences, a division of SGS Belgium NV
More Information
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Responsible Party: Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier: NCT03056326    
Other Study ID Numbers: CCD-06333AA1-01
2015-005552-94 ( EudraCT Number )
First Posted: February 17, 2017    Key Record Dates
Last Update Posted: November 7, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Cystic Fibrosis
Bronchiectasis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
 Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Bronchial Diseases