This study is a Phase IIb, Randomized, Double-blind, Multicenter, Placebo-controlled study evaluating the efficacy and safety of CT-P27 in subjects with acute uncomplicated influenza A infection.
This study is a Phase IIb, Randomized, Double-blind, Multicenter, Placebo-controlled study. All enrolled subjects will be given a single dose of 90 mg/kg CT-P27, 45 mg/kg CT-P27, or placebo intravenously over 90 minutes (±15 minutes) on Day 1 and then followed by Day 110.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
228
Influenza A treatment drug.
Influenza A treatment drug.
Placebo.
Korea University Guro Hospital
Seoul, South Korea
Time to Resolution of Influenza Symptoms and Fever
Time to resolution of influenza symptoms (cough, sore throat, nasal congestion, headache, feeling feverish, body aches and pains, and fatigue) and fever (\<37.8)
Time frame: Twice a day (Morning and Evening) from Day 1 to Day 8
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