Phase 2a MK-4482 Influenza Human Challenge Study in Healthy Participants
Research type
Research Study
Full title
A Phase 2a Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-4482 in Healthy Participants Inoculated with Experimental Influenza Virus
IRAS ID
1007195
Contact name
Gillian Gillespie
Contact email
Sponsor organisation
Merck Sharp & Dohme LLC
Research summary
Part 1: Healthy participants will be infected with newly produced influenza virus, the various components of their blood, the lining of their noses and other samples will be tested in order to measure the effects of the virus on the body before, during and after viral infection. For this research study 20 volunteers, 18-55 years, who consent to the to the participation in this research will be invited to Quarantine unit at hVIVO to stay for 11 days and one follow up clinic visit.
Part2: The purpose is to test the effects of an experimental drug called MK-4482 that may be useful in treating patients infected with influenza, as it may be useful in the prevention of influenza or ‘the flu’. A licensed drug called Oseltamivir (Tamiflu) currently used to treat flu will also be used in the study as a comparator that will be given to some of the participants in the study. 140 healthy participants in 4 groups of 35, aged 18-55 years, who consent to the participation in this study will be orally inoculated with a study influenza virus in one of our Quarantine residential facilities for 11 days. We will then give MK-4482 or Oseltamivir or Placebo to the participants allocated at random in one of the four groups:
1. Early Group - MK-4482 administered orally twice a day, starting 12 hours after inoculation of Influenza virus on Day
2. Late Group - MK-4482 administered orally twice a day, starting 48 hours after inoculation of the influenza virus
3. Active comparator Group - Oseltamivir administered orally twice a day, starting 48 hours after inoculation of the influenza virus.
4. Placebo Group
Participants will be monitored for safety throughout the study and have assessments performed daily during the quarantine period with symptoms collected daily using symptom diary cards and FLU-PRO Plus © questionnaire. Participants will need to return for a final follow up visit approximately 28 days (±3 days) from the date they receive the study virus.REC name
Wales REC 5
REC reference
23/WA/0090
Date of REC Opinion
26 Jul 2023
REC opinion
Further Information Favourable Opinion