This study will be a double-blind, randomized, placebo-controlled study of a single dose
(20mg) of Influenza Antiviral DAS181-F04 for 3 days. The group of nine subjects will be
randomly assigned to DAS181 or placebo at 2:1 ratios. Subjects will be admitted to the
inpatient clinic at a minimum of the night prior to first dose. The subjects will stay in the
inpatient clinic for the duration of dosing and one day after dosing, they will be required
to come back for follow-up visits on study days 4, 6, 9, 16 (+/-1 day), 32 (+/-3 days), and
90 (+/-10 days). The safety parameters will include abnormal laboratory values, adverse
events and clinical observations.
Phase:
Phase 1
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)