Influenza Clinical Trial
This protocol will seek to enroll adult otherwise healthy subjects presenting with influenza-like illness (ILI). Subjects will enter the study based on listed inclusion/exclusion criteria, including a positive diagnostic test for influenza virus (IFV).
This protocol will seek to enroll adult otherwise healthy subjects presenting with
influenza-like illness (ILI). Subjects will enter the study based on listed
inclusion/exclusion criteria, including a positive diagnostic test for influenza virus
(IFV).
Based upon a Rapid Diagnostic Test of IFV, subjects will be randomized into one of three
groups: a single dose DAS181 10 mg group, a multiple dose DAS181 10 mg, 10 mg, 10 mg dose
group or a placebo group.
The full analysis set will include subjects with confirmed influenza as documented with
Rapid Diagnostic Testing. The set will be used for activity analysis and will include all
randomized subjects with baseline and treatment data. Study staff may visit subjects outside
the clinic. Per protocol, the safety analysis sets are described below in Statistical
Methods.
Peripheral venous blood samples for pharmacokinetic (PK) and immunogenic analysis of DAS181
will be obtained on 10 subjects enrolled in each study arm.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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