Back to resultsA Study to Evaluate the Efficacy and Safety of CT-P27 in an Influenza Challenge Model
Primary Purpose
Influenza A
Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
CT-P27
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Influenza A focused on measuring efficacy, safety
Eligibility Criteria
Inclusion Criteria:
- Healthy Male & Female volunteers
Exclusion Criteria:
- Current clinically significant disease
- Pregnant or nursing mother
- Abnormal pulmonary function, nose or nasopharynx
Sites / Locations
- Retroscreen Virology Ltd.
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
CT-P27 10mg/kg
CT-P27 20mg/kg
Placebo
Arm Description
CT-P27 will be administrated once in IV infusion.
CT-P27 will be administrated once in IV infusion.
Placebo will be administrated once in IV infusion.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02071914
Brief Title
A Study to Evaluate the Efficacy and Safety of CT-P27 in an Influenza Challenge Model
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
February 15, 2014 (Actual)
Primary Completion Date
May 19, 2014 (Actual)
Study Completion Date
June 19, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Celltrion
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza A
Keywords
efficacy, safety
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
81 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CT-P27 10mg/kg
Arm Type
Experimental
Arm Description
CT-P27 will be administrated once in IV infusion.
Arm Title
CT-P27 20mg/kg
Arm Type
Experimental
Arm Description
CT-P27 will be administrated once in IV infusion.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo will be administrated once in IV infusion.
Intervention Type
Drug
Intervention Name(s)
CT-P27
Intervention Description
Influenza A treatment drug.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo.
Primary Outcome Measure Information:
Title
Viral Load AUC (Day 1 to Day 9) by Nasopharyngeal Swab Quantitative PCR
Description
AUC of Viral Load, as Measured by Quantitative PCR of Nasopharyngeal Swab, Post-viral Challenge to the Last Assessment Day in Quarantine
Time Frame
Three times a day from Day 1(the day after virus inoculation) to Day 9
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy Male & Female volunteers
Exclusion Criteria:
Current clinically significant disease
Pregnant or nursing mother
Abnormal pulmonary function, nose or nasopharynx
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
SuEun Song
Organizational Affiliation
Celltrion Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Retroscreen Virology Ltd.
City
London
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
A Study to Evaluate the Efficacy and Safety of CT-P27 in an Influenza Challenge Model
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