Study evaluating the effect of GS-5806 in volunteers infected with RSV

• Research type

  Research Study

• Full title

  A Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, and Efficacy of GS-5806 in Healthy Subjects Infected with Respiratory Syncytial Virus (RSV - A Memphis 37b strain)

• IRAS ID

  114130

• Contact name

  Adeyemi Adeyi

• Sponsor organisation

  Gilead Sciences Inc.

• Eudract number

  2012-002413-19

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Study design: This is a randomized, double-blind, placebo-controlled study. Up to a total of 100 subjects will be enrolled (randomized) into approximately 5 sequential quarantines. Subjects will be randomized 1:1 to receive either GS-5806 or placebo. Each subject will be admitted to the Quarantine Unit, and be inoculated with RSV on Day 0 of quarantine. Subjects will be treated with IMP (GS-5806 or placebo) when infection is documented in the nasal wash, or by the 5th day after inoculation, whichever occurs first. The IMP will be administered once daily for 5 days. Upon completion of dosing, subjects will be observed until Day 12 of quarantine, and will then be discharged from quarantine. Number of subjects planned: Quarantines: up to 100 subjects (up to 50 per arm) with 50 reserve subjects. Target population Healthy male and female subjects aged 18 to 45 years inclusive, who are sero-suitable for RSV. Expected duration of participation For each subject, from Screening to final scheduled follow up: approximately 90 days (3 months). Quarantine stay: 15 days. This may be extended if a subject has to stay beyond Day 12 post-inoculation due to ongoing signs and symptoms of RSV, or still has evidence of viral shedding (either by positive Rapid Antigen test or nasal wash). Duration and Frequency of Challenge with RSV 1 inoculation, followed by at least 12 days of quarantine post inoculation. Duration of Treatment with IMP 5 days in total Dose Day 1: 50 mg once Dose Days 2-5: 25 mg once daily

• REC name

  London - City & East Research Ethics Committee

• REC reference

  12/LO/1559

• Date of REC Opinion

  15 Oct 2012

• REC opinion

  Favourable Opinion