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
Overview
- Phase
- Phase 2
- Intervention
- CT-P27 90 mg/kg
- Conditions
- Influenza A
- Sponsor
- Celltrion
- Enrollment
- 228
- Locations
- 1
- Primary Endpoint
- Time to Resolution of Influenza Symptoms and Fever
- Status
- Terminated
- Last Updated
- 3 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
CT-P27 90 mg/kg
CT-P27 will be administrated once in IV infusion.
Intervention: CT-P27 90 mg/kg
CT-P27 45mg/kg
CT-P27 will be administrated once in IV infusion.
Intervention: CT-P27 45 mg/kg
Placebo
Placebo will be administrated once in IV infusion.
Intervention: Placebo
Outcomes
Primary Outcomes
Time to Resolution of Influenza Symptoms and Fever
Time Frame: Twice a day (Morning and Evening) from Day 1 to Day 8
Time to resolution of influenza symptoms (cough, sore throat, nasal congestion, headache, feeling feverish, body aches and pains, and fatigue) and fever (\<37.8)