RV1729 - first doses in humans; ver 1

• Research type

  Research Study

• Full title

  A randomised, double blind, placebo-controlled, three part study to evaluate the safety, tolerability and pharmacokinetics of treatment with single and repeat doses of inhaled RV1729 in healthy subjects and subjects with mild to moderate asthma (HMR code: 12-030)

• IRAS ID

  126428

• Contact name

  Malcolm Boyce

• Eudract number

  2012-005452-42

• ISRCTN Number

  No number provided

• Clinicaltrials.gov Identifier

  No number provided

• Research summary

  RV1729 is an experimental new medicine for asthma and chronic obstructive pulmonary disease.  We hope it’ll reduce inflammation in the lungs by blocking the activity of a substance called Pi3 kinase.  It’s never been given to humans before.  We’ll test RV1729, inhaled as a powder by mouth, in healthy volunteers (Parts A and B) and people with asthma (Part C).  We aim to find any side effects and measure blood levels after dosing.Part A (single doses)We’ll study up to 3 groups.* Group 1 (10 participants) will have 5 study sessions. * Group 2 (8 participants) will have 4 study sessions.Participants will take placebo in one session, and RV1729 in the other sessions.  They’ll stay on the ward for 2 nights in each session, and make 2 outpatient visits.  They’ll take up to 11 weeks to finish the study.  We may study another dose of RV1729 in Group 3:  8 participants would take a single dose of RV1729 or placebo.  They’d stay on the ward for 2 nights, make 2 outpatient visits, and take up to 7 weeks to finish the study.Parts B and C (repeated doses)2 groups of 9 healthy volunteers and 2 groups of 9 people with asthma will take 7 daily doses of RV1729 or placebo.  They’ll stay on the ward for 8 nights, make up to 3 outpatient visits, and take up to 8 weeks to finish the study.In each part of the study, we’ll start with a small dose, and increase the dose as the study progresses.A pharmaceutical company (RespiVert Ltd) is paying for the study.The study will take place at 2 centres: 1 in London and 1 in Manchester.  We’ll recruit volunteers by advertising (newspaper, radio, and websites), word of mouth, volunteer databases, and our websites. Â

• REC name

  London - Brent Research Ethics Committee

• REC reference

  13/LO/0380

• Date of REC Opinion

  8 Apr 2013

• REC opinion

  Favourable Opinion