To Evaluate the Efficacy and Safety of CT-P27 in an Influenza Challenge Model
This trial is active, not recruiting.
|Start date||February 2014|
|End date||May 2014|
|Trial size||81 participants|
|Trial identifier||NCT02071914, CT-P27/2.1|
This study is to evaluate the efficacy of CT-P27 measured by quantitative PCR viral load from nasopharyngeal mucosa, compared to placebo.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, investigator)|
CT-P27 10mg/kg IV in 90 minutes
CT-P27 20mg/kg IV in 90 minutes
Placebo IV in 90 minutes
AUC of post-challenge nasopharyngeal viral load measured by quantitative PCR of nasopharyngeal swab
time frame: three in a day from Day 1(the day after virus inoculation) to Day 9
Male or female participants from 18 years up to 45 years old.
Inclusion Criteria: - Healthy Male & Female volunteers Exclusion Criteria: - Current clinically significant disease - Pregnant or nursing mother - Abnormal pulmonary function, nose or nasopharynx
|Official title||A Randomised, Double-Blind, Placebo-Controlled, Single-Centre, Phase IIa Study in Healthy Volunteers to Evaluate the Efficacy and Safety of CT-P27 in an Influenza Challenge Model|
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