The effects of RPL554 on inhaled LPS challenge in healthy volunteers
Research type
Research Study
Full title
Randomised, double-blind, placebo-controlled, crossover study to determine the anti-inflammatory effects of 6 repeated daily doses of nebulised 0.018mg/kg RPL554 on inhaled Lipopolysaccharide challenge in healthy volunteers
IRAS ID
102935
Contact name
S D Singh
Contact email
Sponsor organisation
Verona Pharma plc
Eudract number
2012-000742-34
Research summary
This is a single-centre, randomised, double-blind, placebo-controlled, 2-way crossover study. Up to 24 healthy non-smoking men and non- child bearing women will be randomised in a 1:1 ratio to receive nebulised RPL554 (0.018mg/kg) or placebo once daily for 6 days during each of the two treatment periods in a cross-over design. A lipopolysaccharide (LPS) challenge will be performed on day 6 of each treatment period. Sputum induction will be performed at 6 hours post LPS challenge. The primary objective is to investigate the anti-inflammatory effect of RPL554 on the last day of dosing in terms of changes in the neutrophil content on hypertonic saline induced sputum after LPS challenge. The secondary objective is to investigate the effects on the total counts of other inflammatory cell types, safety effects (i.e. any major ECG, heart rate and blood pressure changes), and pharmacokinetics.
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
12/NW/0376
Date of REC Opinion
30 May 2012
REC opinion
Further Information Favourable Opinion