A Study to Evaluate the Efficacy and Safety of CT-P27 in an Influenza Challenge Model
- Registration Number
- NCT02071914
- Lead Sponsor
- Celltrion
- Brief Summary
This study is to evaluate the efficacy of CT-P27 measured by quantitative PCR viral load from nasopharyngeal mucosa, compared to placebo.
- Detailed Description
This study is a Randomised, Double-Blind, Placebo-Controlled, Single-Centre, Phase IIa study. All enrolled subjects will be given a single dose of 10 mg/kg CT-P27, 20 mg/kg CT-P27, or placebo intravenously and then followed by Day 36.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 81
Inclusion Criteria
- Healthy Male & Female volunteers
Exclusion Criteria
- Current clinically significant disease
- Pregnant or nursing mother
- Abnormal pulmonary function, nose or nasopharynx
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo will be administrated once in IV infusion. CT-P27 20mg/kg CT-P27 CT-P27 will be administrated once in IV infusion. CT-P27 10mg/kg CT-P27 CT-P27 will be administrated once in IV infusion.
- Primary Outcome Measures
Name Time Method Viral Load AUC (Day 1 to Day 9) by Nasopharyngeal Swab Quantitative PCR Three times a day from Day 1(the day after virus inoculation) to Day 9 AUC of Viral Load, as Measured by Quantitative PCR of Nasopharyngeal Swab, Post-viral Challenge to the Last Assessment Day in Quarantine
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Retroscreen Virology Ltd.
🇬🇧London, United Kingdom