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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.

Tracking Information
First Submitted Date  ICMJE February 3, 2017
First Posted Date  ICMJE February 17, 2017
Last Update Posted Date November 7, 2017
Study Start Date  ICMJE November 2016
Actual Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 14, 2017)
  • Adverse events [ Time Frame: Part 1 from Day 1 to 5, Part 2 from Day 1 to 15 ]
    Treatment-related Adverse events
  • Change in Vital signs [ Time Frame: Part 1 from Day 1 to 5, Part 2 from Day 1 to 15 ]
    Blood pressure
  • Heart Rate [ Time Frame: Part 1 Day 1-2, Part 2 Day 1-2 and Day 14-15 ]
    Change in Heart Rate (from ECG)
  • QTcF interval [ Time Frame: Part 1 Day 1-2, Part 2 Day 1-2 and Day 14-15 ]
    Change in QTcF interval (from ECG)
  • PR interval [ Time Frame: Part 1 Day 1-2, Part 2 Day 1-2 and Day 14-15 ]
    Change in PR interval (from ECG)
  • QRS interval [ Time Frame: Part 1 Day 1-2, Part 2 Day 1-2 and Day 14-15 ]
    Change in QRS interval (from ECG)
  • Holter recording abnormalities [ Time Frame: Part 1 Day 1-2, Part 2 Day 1-2 and Day 14-15 ]
    24h-holter ECG recording
  • FEV1 [ Time Frame: Part 1 Day 1-2, Part 2 Day 1-14-15 ]
    Change in FEV1 (Forced exhalation volume in the first second)
  • Clinical chemistry and haematology [ Time Frame: Part 1 Day 1-5, Part 2 Day 1-15 ]
    change in Clinical chemistry and haematology parameters
  • Urinalysis [ Time Frame: Part 1 Day 1-5, Part 2 Day 1-15 ]
    Change in urinalysis parameters
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 14, 2017)
  • Area under the plasma concentration [ Time Frame: Part 1 from Day 1 to 5, Part 2 from Day 1-2 and Day 14-15 ]
  • 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
  • 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 ]
  • Elimination half-life (t1/2) [ Time Frame: Part 1 from Day 1 to 5, Part 2 from Day 1-2 and Day 14-15 ]
  • 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
  • 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
  • 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
  • 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
  • Renal clearance (CLr) [ Time Frame: Part 1 from Day 1 to 5, Part 2 from Day 1-2 and Day 14-15 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Investigate Safety, Tolerability and Pharmacokinetics of Single and Repeat Doses of CHF6333 in Healthy Subjects
Official Title  ICMJE 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
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

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE 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
Condition  ICMJE
  • Non-Cystic Fibrosis Bronchiectasis
  • Cystic Fibrosis
Intervention  ICMJE
  • Drug: CHF6333 (Part 1 - SAD)
    Single doses of CHF6333 at each period
  • Drug: Placebo (Part 1 - SAD)
    Single doses of placebo matching CHF6333 at each period
  • Drug: CHF6333 (Part 2 - MAD)
    once daily multiple doses of CHF6333 for 14 days
  • Drug: Placebo (Part 2 - MAD)
    once daily multiple doses of placebo matching CHF6333 for 14 days
Study Arms  ICMJE
  • Experimental: CHF6333 Active
    Interventions:
    • Drug: CHF6333 (Part 1 - SAD)
    • Drug: CHF6333 (Part 2 - MAD)
  • Placebo Comparator: Placebo
    Interventions:
    • Drug: Placebo (Part 1 - SAD)
    • Drug: Placebo (Part 2 - MAD)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 14, 2017)
72
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2017
Actual Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03056326
Other Study ID Numbers  ICMJE CCD-06333AA1-01
2015-005552-94 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Chiesi Farmaceutici S.p.A.
Study Sponsor  ICMJE Chiesi Farmaceutici S.p.A.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Frédéric Vanhoutte SGS Life Sciences, a division of SGS Belgium NV
PRS Account Chiesi Farmaceutici S.p.A.
Verification Date November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP