RV568 — first doses in humans; version 1

• Research type

  Research Study

• Full title

  A randomised, single-blind, placebo-controlled, cross-over, dose-escalation study to assess the safety and tolerability of single, intranasal and inhaled doses of RV568 in healthy volunteers combined with a randomised, single-blind, placebo-controlled, parallel group to assess the safety and tolerability of 7-day repeat doses of intranasal and inhaled RV568 in healthy volunteers (HMR code 09-016)

• IRAS ID

  53460

• Contact name

  Steve Warrington

• Eudract number

  2010-019978-33

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  RV568 is a new medicine being developed to treat asthma, chronic obstructive pulmonary disease (COPD) and hayfever. In asthma and COPD, inflammation in the lungs causes swelling and irritation of the air passages, making it difficult to breathe. In hayfever, an allergic reaction to pollen causes irritation of the eyes and nose. The purpose of this study is to test if RV568 is safe and well tolerated. We'll also measure the amount of RV568 in the blood, to see how quickly RV568 is absorbed and how long it stays in the body after it??s inhaled into the lungs, or given as drops into the nose. In this study, We'll compare RV658 with a placebo (dummy medicine). About 54 healthy men aged 18??50 years will be recruited into 5 groups. The study is in two parts: in Part A (Groups 1 and 2) We'll give RV568 as drops into the nose; and in Part B Groups 3, 4 and 5 will inhale RV568 into the lungs. Participants in Groups 1, 3 and 4 will receive single doses of RV568. Each week We'll give a higher dose of RV568, if no important side effects occur. Participants will stay in the research unit for 2 nights each week. Participants in Groups 2 and 5 will receive RV568 once daily for 7 days, and will stay at the research unit for 8 nights. Participants will complete the study in 7??11 weeks, depending on which group they??re in. This study will take place at a specialist research centre in London. We'll recruit participants by advertising (newspaper, radio, and websites), word of mouth, from volunteer databases, and via our websites. RespiVert Ltd is paying for the study

• REC name

  London - Brent Research Ethics Committee

• REC reference

  10/H0717/30

• Date of REC Opinion

  27 May 2010

• REC opinion

  Favourable Opinion