An assessment of a monoclonal antibody, against Influenza A
Research type
Research Study
Full title
A Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study in Healthy Volunteers to Evaluate the Efficacy and Safety of MHAA4549A in an Influenza Challenge Model
IRAS ID
136870
Contact name
Hosneih Fathi
Contact email
Sponsor organisation
Genentech Inc.
Eudract number
2013-001983-52
Research summary
This is a Phase IIa, randomised, double-blinded study to evaluate the effect of study drug MHAA4549A compared to placebo (dummy) on the development of clinical influenza symptoms and virus shedding from healthy volunteers.
There are up to five stages to this study (the fifth stage is optional and dependant on the outcome of the previous four stages). The study procedures and assessments will be the same for each study stage; the number of subjects and the treatments will differ between stages.
Volunteers will be screened to identify eligible subjects to participate in the study. At the study specific screening visit volunteers will provide informed consent and undergo the scheduled screening assessments which will include a blood test to assess the presence of antibodies to the influenza virus.
Eligible volunteers will be asked to attend the Quarantine facility on Day -2/-1 (prior to viral challenge).
In Stages, up to 100 randomised volunteers will be inoculated (challenged) with the influenza virus strain (A/Wisconsin/67/2005 (H3N2)) and approximately 24 hours later (Day 1), dosed in a blinded fashion with MHAA4549A or placebo (Stage 1-4). In Stage 5, a group may be dosed with oseltamivir (Tamiflu) or oseltamivir placebo.
A sentinel group of six volunteers will undergo MHAA4549A dosing and viral challenge approximately two days before volunteers in the first group of the next Stage are dosed.
Volunteers will remain in the Quarantine facility for approximately 11 days; until Day 8, or longer at the Investigator’s discretion. A 5-day course of anti-viral medication (oseltamivir or appropriate alternative) will commence on Day 7 (3 doses will be taken while in quarantine; the regimen will be completed at home).
Following discharge from quarantine, volunteers will attend 5 follow-up visits at approximately 15, 29, 57, 85 and 120 days after exposure to the study influenza virus.REC name
London - City & East Research Ethics Committee
REC reference
13/LO/1241
Date of REC Opinion
17 Sep 2013
REC opinion
Favourable Opinion