CHF6297 FIM
Research type
Research Study
Full title
A randomised, double-blind, placebo-controlled study to investigate the safety, tolerability and pharmacokinetics of CHF 6297 after single and repeated ascending doses in healthy male subjects followed by a repeated dose in COPD patients and a 2-way, crossover, double-blind, placebo-controlled, repeated dose part to investigate the anti-inflammatory effect of CHF 6297 after Lipopolysaccaride (LPS) challenge in healthy male subjects.
IRAS ID
192854
Contact name
Sara Collarini
Contact email
Sponsor organisation
Chiesi Farmaceutici S.p.A.
Eudract number
2015-003075-30
Duration of Study in the UK
1 years, 2 months, 1 days
Research summary
The Sponsor is developing the study drug, CHF 6297, for the potential treatment of chronic obstructive pulmonary disease (COPD). COPD is the name given to a collection of lung diseases. Patients suffer breathing difficulties primarily as a result of narrowing of the airways, they also report a chronic cough and frequent chest infections.
The study has been designed to look at the safety of CHF 6297, how the body tolerates the drug and how the drug is taken up by the body when given at different doses.
The study will consist of 4 parts involving up to 136 healthy male and female subjects. In Part 1, up to 24 male subjects will be split into two cohorts of 12 and will receive 3 ascending doses of the study drug. Cohort A will begin on 2mg and increase to 32mg and cohort B will begin on 4mg and increase to 40mg. In Part 2, healthy male subjects will be divided into four cohorts of 12 with each receiving 4mg, 12mg, 24mg or 40mg dose levels daily for 7 days. During each part, 9 out of the 12 subjects within the cohort will receive the active drug CHF 6297 and 3 will receive placebo.
Part 3 will include male and female COPD patients who will receive repeated administrations of CHF 6297 at one dose level over 14 days. The dose will be decided after Part 2. 30 COPD patients will be included in this part; 20 will receive the active drug and 10 patients will receive placebo. In Part 4, healthy male subjects will receive repeated administration of CHF 6297 at one dose level for 7 consecutive days before inhaling a compound that will trigger the release of inflammatory messengers in the lungs, mimicking the characteristic lung inflammation in COPD.
REC name
Wales REC 2
REC reference
15/WA/0371
Date of REC Opinion
20 Nov 2015
REC opinion
Favourable Opinion