Retroscreen Ltd
London, NW1 0NH, United Kingdom
NCT Number: NCT01980966
This randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of MHAA4549A in healthy volunteers in an influenza challenge model. Subjects will be intranasally oculated with the challenge virus and will be randomly assigned to receive a intravenous dose of either MHAA4549A or placebo. In the stage 5 cohort, subjects will be randomly assigned to receive doses of MHAA4549A or placebo or Tamiflu (oseltamivir) orally twice daily for 5 days. All subjects in all cohorts may take Tamiflu twice daily from Day 7 to Day 11.
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Notify Me18 year–45 year
All sexes
Interventional
Phase 2
London, NW1 0NH, United Kingdom
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
IV dose
IV dose
Orally b.i.d, 5 days
Time frame: 8 days
Time frame: 120 days
Time frame: from pre-challenge to Day 29
Time frame: 120 days
Time frame: 8 days
Time frame: 8 days
Time frame: 8 days
Time frame: 8 days
Time frame: 8 days
Time frame: 8 days
Genentech, Inc.
Industry
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
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