A Study to Evaluate the Efficacy and Safety of CT-P27 in Acute Uncomplicated Influenza A Infection

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 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.

Inclusion Criteria:

• Male or Female subjects between the ages of 19 and 64 years, both inclusive
• Diagnosed with influenza A at screening using rapid influenza diagnostic test
• Onset of influenza symptoms and fever is within 48 hours at screening
• At least 2 of symptoms (moderate to severe in intensity)
• ≥38.0'C body temperature at screening

Exclusion Criteria:

• Taking antiviral treatment for influenza or has a history of using these antivirals within 14 days prior to the administration of study drug
• Positive influenza B or A+B infection