A Phase 2a Randomized, Double-blind, Placebo-controlled Trial with Open-label Dose-finding Cohorts to Evaluate the Efficacy and Safety of CR9114 Monoclonal Antibody Administered as Intranasal Doses in Healthy Adult Participants who are Challenged with a Live, Wild-type Influenza Type A Virus (A/Belgium/4217/2015 H3N2)

Influenza virus

Incidence of MMIDa as measured by the InFLUenza Patient Reported Outcome (FLU-PRO) Plus©., Frequency and severity of treatment-emergent adverse events (TEAE) and SAEs.

Area under the curve (AUC) of the influenza ribonucleic acid (RNA) log10 viral load, Peak influenza RNA log10 viral load, and influenza RNA log10 viral load actual values by time/visit by real-time quantitative reverse transcription PCR (qRT-PCR) starting on the second day after challenge (Day 3) until discharge (Day 11)., Proportion of participants with infection following challenge virus inoculation as determined by qRT-PCR. Infection is defined as at least 2 consecutive qRT-PCR positive nasopharyngeal swabs starting on the second day after challenge (Day 3)., Viral shedding duration by qRT-PCR and qCulture., Viral shedding quantitation by qRT-PCR and qCulture., Symptom duration/time to onset of symptoms/time to symptom resolution/time to peak symptoms/peak symptom score/total clinical symptom score by day/FLU-PRO domain/system score as measured by the FLU-PRO Plus©., Total number of symptoms experienced with or without laboratory-confirmed influenza illness as measured by the FLU-PRO Plus© and qRT-PCR., Number of participants with upper respiratory tract infection, lower respiratory tract infection, systemic illness as measured by the FLU-PRO Plus©., Proportion of participants with FLU-PRO Plus© score 3 or higher among participants with and without laboratory-confirmed influenza illness as measured by the FLU-PRO Plus© and qRT-PCR., Proportion of participants without symptoms as measured by the FLU-PRO Plus©., Proportion of participants without laboratory-confirmed influenza as measured by qRT-PCR., PK of CR9114 in serum., Presence of anti-CR9114 Abs in serum.

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Belgium