VR942 - first doses in humans; version 1
Research type
Research Study
Full title
A randomised, double-blind, placebo-controlled, dose-escalation study to evaluate the safety, tolerability, pharmacodynamics and pharmacokinetics of single inhaled doses of VR942 in healthy subjects and repeated doses in mild asthmatics (14-017)
IRAS ID
169850
Contact name
Malcolm Boyce
Contact email
Sponsor organisation
Vectura Ltd
Eudract number
2014-004831-37
Duration of Study in the UK
0 years, 12 months, 00 days
Research summary
VR942 is an experimental new medicine for treating some types of severe respiratory disease and we hope it will reduce inflammation (swelling and soreness) in the lungs. VR942 will be inhaled as a powder using a new inhaler.
We’ll test single doses of VR942 in healthy volunteers and repeated doses of VR942 in volunteers with mild disease to find out its side effects and blood levels, and how the body reacts to it. We’ll also check the effect of repeated doses in volunteers with mild disease. Lastly, we aim to find out if the new inhaler works as intended.
The study will be done in 2 parts and will include 93 volunteers, aged 18–50 years, as follows.
* In Part 1, we’ll give 40 healthy volunteers single doses of VR942 or placebo. VR942 has never been given to humans before, so we’ll start with a small dose, and increase the dose as the study progresses. Volunteers will stay on the ward for 4 nights, and make 3 outpatient visits. They’ll take up to 8 weeks to finish the study.
* In Part 2, we’ll give 53 volunteers with mild disease 10 once daily doses of VR942 or placebo. Again, we’ll start with a small dose, and increase the dose as the study progresses. Volunteers will stay on the ward for 14 nights, and make 2 outpatient visits. They’ll take up to 8 weeks to finish the study.
Vectura Ltd is funding the study.
The study will take place at 1 centre in London.
REC name
Scotland A REC
REC reference
15/SS/0004
Date of REC Opinion
27 Jan 2015
REC opinion
Favourable Opinion