Phase 2B Study on Safety and Therapeutic Efficacy of DAS181 in Adult Subjects With Naturally Acquired Influenza
Status:
Completed
Trial end date:
2014-01-01
Target enrollment:
Participant gender:
Summary
This protocol will seek to enroll 372 adult otherwise healthy subjects presenting with
influenza-like illness (ILI). Subjects will enter the study based on listed
inclusion/exclusion criteria, including a positive Rapid Antigen Test (RAT) for influenza
virus (IFV).
Subjects will be randomized into one of three treatment groups: a DAS181 30 mg total dose
group (DAS181-F02 formulation), a DAS181 60 mg total dose group (DAS181-F04 formulation) or a
placebo group.
The modified intent to treat (mITT) analysis set will include subjects with confirmed
influenza as documented by qPCR or TCID50. The full analysis set will be used for activity
analysis and will include all randomized subjects with baseline and treatment data. Per
protocol, the safety analysis sets are described below in statistical methods.
A subpopulation of 60 participants will also have additional PK and Immunogenicity blood
samples collected. For this subgroup, PK and Immunogenicity samples will be collected at all
study visits.