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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
101
Retroscreen Ltd
London, United Kingdom
Viral area under the concentration-time curve (AUC) of nasopharyngeal viral load by quantitative Polymerase Chain Reaction (qPCR)
Time frame: 8 days
Safety: Incidence of adverse events
Time frame: 120 days
Safety: Change in lung function
Time frame: from pre-challenge to Day 29
Safety: Incidence of anti-therapeutic antibodies (ATAs)
Time frame: 120 days
Pharmacokinetics: Area under the concentration-time curve
Time frame: 8 days
AUC of nasopharyngeal viral load, as measured by cell culture
Time frame: 8 days
Peak viral load (qPCR and cell culture)
Time frame: 8 days
Duration of viral shedding
Time frame: 8 days
Duration of Grade 2 or worse symptoms (from first occurrence of any Grade >2 symptom to last occurrence of any Grade >2 symptom)
Time frame: 8 days
Peak/AUC of composite symptoms
Time frame: 8 days
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