NCT02071914

A Study to Evaluate the Efficacy and Safety of CT-P27 in an Influenza Challenge Model

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 81 (actual)
• Sponsor: Celltrion · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Influenza A

Interventions

Type	Name	Description
DRUG	CT-P27	Influenza A treatment drug.
DRUG	Placebo	Placebo.

Timeline

• Start date: 2014-02-15
• Primary completion: 2014-05-19
• Completion: 2014-06-19
• First posted: 2014-02-26
• Last updated: 2020-04-08
• Results posted: 2020-03-16

Locations

1 site across 1 country: United Kingdom