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NCT02071914 Clinical Trial

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

Influenza A Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02071914
Other study ID # CT-P27 2.1
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date February 15, 2014
Est. completion date June 19, 2014

Study information
Verified date March 2020
Source Celltrion
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is to evaluate the efficacy of CT-P27 measured by quantitative PCR viral load from nasopharyngeal mucosa, compared to placebo.

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 information / eligibility
Status Completed
Enrollment 81
Est. completion date June 19, 2014
Est. primary completion date May 19, 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- Healthy Male & Female volunteers

Exclusion Criteria:

- Current clinically significant disease

- Pregnant or nursing mother

- Abnormal pulmonary function, nose or nasopharynx

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• CT-P27
Influenza A treatment drug.
• Placebo
Placebo.

Locations
Country Name City State
United Kingdom Retroscreen Virology Ltd. London

Sponsors (1)
Lead Sponsor Collaborator
Celltrion

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Viral Load AUC (Day 1 to Day 9) by Nasopharyngeal Swab Quantitative PCR AUC of Viral Load, as Measured by Quantitative PCR of Nasopharyngeal Swab, Post-viral Challenge to the Last Assessment Day in Quarantine Three times a day from Day 1(the day after virus inoculation) to Day 9
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