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

March 25, 2020 updated by: Celltrion

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

81

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy Male & Female volunteers

Exclusion Criteria:

  • Current clinically significant disease
  • Pregnant or nursing mother
  • Abnormal pulmonary function, nose or nasopharynx

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Placebo will be administrated once in IV infusion.
Drug: Placebo
Placebo.
EXPERIMENTAL: CT-P27 10mg/kg
CT-P27 will be administrated once in IV infusion.
Drug: CT-P27
Influenza A treatment drug.
EXPERIMENTAL: CT-P27 20mg/kg
CT-P27 will be administrated once in IV infusion.
Drug: CT-P27
Influenza A treatment drug.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Viral Load AUC (Day 1 to Day 9) by Nasopharyngeal Swab Quantitative PCR
Time Frame: Three times a day from Day 1(the day after virus inoculation) to Day 9
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Celltrion

Investigators

  • Study Director: SuEun Song, Celltrion Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 15, 2014

Primary Completion (ACTUAL)

May 19, 2014

Study Completion (ACTUAL)

June 19, 2014

Study Registration Dates

First Submitted

February 24, 2014

First Submitted That Met QC Criteria

February 24, 2014

First Posted (ESTIMATE)

February 26, 2014

Study Record Updates

Last Update Posted (ACTUAL)

April 8, 2020

Last Update Submitted That Met QC Criteria

March 25, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CT-P27 2.1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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