To Evaluate the Efficacy and Safety of CT-P27 in an Influenza Challenge Model
Not Applicable
Completed
- Conditions
- Diseases of th respiratory system
- Registration Number
- KCT0001180
- Lead Sponsor
- Celltrion
- Brief Summary
Not available
- Detailed Description
Not available
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
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method AUC of post-challenge nasopharyngeal viral load measured by quantitative PCR of nasopharyngeal swab
- Secondary Outcome Measures
Name Time Method To evaluate reduction in total AUC influenza composite symptoms post viral challenge & reduction in the incidence of influenza infection in the CT-P27 groups compared to the placebo