Placebo-controlled study investigating the effects of intranasal RV568

• Research type

  Research Study

• Full title

  A randomized, single-blind, placebo-controlled, parallel group study to investigate the effects of intranasal RV568 (400µg) administered twice daily to adult male volunteers experimentally inoculated with live Respiratory Syncytial Virus.

• IRAS ID

  59656

• Contact name

  Anthony Gilbert

• Sponsor organisation

  RespiVert Ltd

• Eudract number

  2010-021527-26

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  This is a randomised, single-blind, placebo-controlled, parallel group study which will assess the effects of the study drug, RV568, on healthy adult male volunteers who are exposed to a Respiratory Syncytial Virus (known as RSV) during a 15-16 day quarantine period. Approximately 300 volunteers will be screened in order to identify 95 subjects who are potentially susceptible to RSV, and up to 72 of these subjects will be dosed with RSV during several quarantine sessions. Volunteers will attend a screening visit to confirm their health and suitability, and then will be allocated to a quarantine session (labeled Day -3 ?? Day 12/13). During the quarantine, a total of 20 (400 microgram) doses of RV568 or placebo (1:1 ratio) will be administered to each subject via the nose. Subjects will receive each dose twice daily starting on Day -1. On Day 0, they will be administered the RSV. Dosing with RV568 will continue through to Day 8, and subjects will be medically monitored until they are fit for discharge on Day 12 or 13. The primary objective of the study is to assess the effects of these repeated intranasal doses of RV568 on the levels of an inflammatory marker, known as interleukin 8, found in the nose following exposure to RSV. The secondary objectives of the study include the assessment of: the effects of intranasal RV568 on the quantity of RSV in the nasal cavities following exposure to RSV; the effect of RV568 on infectivity rates; the effect on the volunteer's clinical symptoms, paper tissue counts and mucus weight; the effects of RV568 on another nasal inflammatory marker (IL6); the effect of RV568 on viable virus cell counts; the safety of the manufactured RSV administered; and the safety of repeated intranasal administration of RV568.

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  10/IEC04/20

• Date of REC Opinion

  14 Sep 2010

• REC opinion

  Further Information Favourable Opinion