A Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Dose in Healthy Volunteers, Repeat Doses in Asthmatic Patients and of Single Dose in COPD Patients of CHF6366

Study Identifier:
CCD-06366AA1-01
ClinicalTrials.gov Identifier:
NCT03378648
EudraCT Identifier:
2015-005551-27
EU CT ID:
N/A
Study Contact Information:
N/A
Study Complete

Study Details

Medical Condition
  • Asthma
  • Chronic Obstructive Pulmonary Disease
Study Drug
  • Drug: CHF6366
  • Drug: Placebo CHF6366
  • Drug: umeclidinium bromide and vilanterol trifenatate
Date
Dec 2017 - Apr 2019
Patient Requirements
Sex: Female & Male
Age: 18 - 75 Years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
  • Part 1
  • male subjects aged 18-55 years inclusive;
  • healthy subjects based on medical evaluation including medical history,physical examination, laboratory tests and cardiac testing
  • Body Mass Index (BMI) between 18.5 and 32.0 kg/m2 extremes inclusive
  • Non- or ex-smokers who smoked \< 5 pack years (pack-years = the number of cigarette packs per day times the number of years) and stopped smoking \> 1 year;
  • Good physical and mental status, determined on the basis of the medical history and a general clinical examination;
  • Lung function equal to or more than 80% of predicted normal value and FEV1/FVC ratio \> 0.70;
  • Part 2
  • Adult male and female subjects aged 18 to 75 years
  • Clinical diagnosis of mild persistent asthma
  • FEV1 reversibility of ≥ 12% or 200 ml over the baseline value starting within 30 mins after inhalation of 400 micrograms of salbutamol
  • Patients who are otherwise healthy as determined by medical history, physical examination, 12-lead ECG findings
  • Part 3
  • Male aged between 40 and 75 years
  • Stable patients with a post-bronchodilator 40% ≤ FEV1 \< 80% of the predicted normal value, post-bronchodilator FEV1/FVC \< 0.7 with salbutamol
  • Current smokers and ex-smokers
  • Response to ipratropium bromide defined as an increase in FEV1 of \> 7 % starting 30 minutes after inhalation of 80 micrograms ipratropium bromide
  • Response to salbutamol defined an increase in FEV1 of \> 7 % starting 15 minutes to 30 min following inhalation of 400 micrograms salbutamol MDI
Exclusion Criteria
  • Part1
  • Any clinically relevant abnormabilites and/or uncontrolled diseases
  • Abnormal laboratory values
  • Recent respiratory tract infection
  • Hypersensitivity to the drug excipients
  • Positive serology results
  • Positive cotinine, alcohol, drug of abuse tests
  • Part 2
  • Pregnant and/or breast-feeding women
  • Subjects with a medical history or current diagnosis of COPD or any other pulmonary disease other than asthma
  • Subjects who have cardiovascular condition
  • Clinically significant laboratory abnormalities
  • Subject with serum potassium level below the lower limit of the laboratory reference range
  • History of alcohol, substance or drug abuse
  • Hypersensitivity to the drug excipients
  • Part 3
  • Female patients
  • Current diagnosis of asthma or allergic rhinitis or other atopic disease
  • Recent COPD exacerbations or a lower respiratory tract infection
  • Hypersensitivity to drug excipients;
  • Abuse of substance or drug t or with a positive urine drug screen
  • Unstable concurrent disease
  • Subjects who have cardiovascular condition
  • Clinically significant laboratory abnormalities indicating a significant or unstable concomitant disease
  • Patients with serum potassium levels below the lower limit of the laboratory normal range
Healthy Volunteers
Yes

Protocol Summary

CHF6366 is a novel bifunctional compound displaying both muscarinic receptor antagonist and β2-adrenergic receptor agonist properties (MABA), with the potential to deliver optimal bronchodilation after inhalation dosing via two validated mechanisms in one molecule.

The study will consist of three parts:

Part 1 will consit of two cohorts of healthy male subjects to assess the safety, tolerability and pharmacokinetics of Single Ascending Dose (SAD) of CHF 6366

Part 2 will consist of four cohorts of asthmatic subjects to assess the saftey, tolerability and pharmacokinetics of Multiple Ascending Dose (MAD) of CHF6366

Part 3 will consist of one cohort of COPD patients to asess safety, tolerability of a single dose of CHF6366 in an active and placebo controlled design

Study Locations

Location
Status
Location
Medicines Evaluation Unit
Manchester, United Kingdom
Status
N/A