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NCT Number: NCT03056326

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

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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Key information

Conditions

Non-cystic Fibrosis Bronchiectasis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cystic Fibrosis Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Pancreatic Diseases Respiratory Tract Diseases

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

SGS Life Sciences

Antwerp, 2060, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CHF6333 (Part 1 - SAD)

Drug

Single doses of CHF6333 at each period

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Chiesi Farmaceutici S.p.A.

Industry

Registry information

Official study 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

Acronym: CHF6333 FIH

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Feb 17, 2017
Registry last updated
Nov 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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