This trial is active, not recruiting.

Condition influenza
Treatments ct-p27, placebo
Phase phase 2
Sponsor Celltrion
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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
CT-P27 10mg/kg IV in 90 minutes
CT-P27 20mg/kg IV in 90 minutes
(Placebo Comparator)
Placebo IV in 90 minutes

Primary Outcomes

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

Eligibility Criteria

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in June 2014.
Information provided to ClinicalTrials.gov by Celltrion.