CCI15106-CFI – first doses in humans; version 1
Research type
Research Study
Full title
A double-blind (sponsor unblind), randomized, placebo-controlled, single and repeat escalating dose study to investigate the safety, tolerability, and pharmacokinetics of CCI15106 capsules for inhalation in healthy subjects and patients with moderate chronic obstructive pulmonary disease (COPD)(15-026)
IRAS ID
195624
Contact name
Malcolm Boyce
Contact email
Sponsor organisation
GlaxoSmithKline
Eudract number
2015-003960-35
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
Chronic obstructive pulmonary disease (COPD) is a condition where the airways in the lungs become damaged and inflamed (swollen and irritated). People with COPD are more likely than healthy people to get virus infections in their lungs. CCI15106 CFI (the study medicine) is a dry powder that’s inhaled through the mouth via a new inhaler. We hope that the study medicine will help COPD patients fight virus infections in their lungs. \n\nWe’ll test single and repeated doses of CCI15106 CFI in healthy volunteers and volunteers with COPD to find out its side effects and blood levels. We’ll also measure how much of the study medicine gets into the lungs of healthy volunteers. Lastly we aim to find out if the inhaler works as intended. \n\nThe study will be done in 3 parts and will include 92 healthy volunteers and 10 volunteers with COPD. CCI15106 CFI has never been given to humans before, so we’ll start with a small dose, and increase the dose as the study progresses. \n\n* In Part 1, we’ll give 54 healthy volunteers single doses of CCI15106 CFI or placebo. Volunteers will stay on the ward for 2 nights, make 2 outpatient visits, and take up to 9 weeks to finish the study.\n\n* In Part 2, we’ll give 38 healthy volunteers CCI15106 CFI or placebo twice daily for 14 days. Volunteers will stay on the ward for 15 nights, make 2 outpatient visits, and take up to 11 weeks to finish the study.\n\n* In Part 3, we’ll give 10 volunteers with COPD a single dose of CCI15106 CFI or placebo. Volunteers will stay on the ward for 2 nights, make 2 outpatient visits, and take up to 9 weeks to finish the study.\n\nA pharmaceutical company GlaxoSmithKline is funding the study.\n\nThe study will take place at 1 centre in London.\n
REC name
HSC REC B
REC reference
16/NI/0001
Date of REC Opinion
19 Jan 2016
REC opinion
Favourable Opinion