A Study to Evaluate the Efficacy and Safety of CT-P27 in Acute Uncomplicated Influenza A Infection

October 28, 2022 updated by: Celltrion

A Phase IIb, Randomized, Double-blind, Multicenter, Placebo-controlled Study Evaluating the Efficacy and Safety of CT-P27 in Subjects With Acute Uncomplicated Influenza A Infection

This study is a Phase IIb, Randomized, Double-blind, Multicenter, Placebo-controlled study evaluating the efficacy and safety of CT-P27 in subjects with acute uncomplicated influenza A infection.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

This study is a Phase IIb, Randomized, Double-blind, Multicenter, Placebo-controlled study. All enrolled subjects will be given a single dose of 90 mg/kg CT-P27, 45 mg/kg CT-P27, or placebo intravenously over 90 minutes (±15 minutes) on Day 1 and then followed by Day 110.

Study Type

Interventional

Enrollment (Actual)

228

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

19 years to 64 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or Female subjects between the ages of 19 and 64 years, both inclusive
  • Diagnosed with influenza A at screening using rapid influenza diagnostic test
  • Onset of influenza symptoms and fever is within 48 hours at screening
  • At least 2 of symptoms (moderate to severe in intensity)
  • ≥38.0'C body temperature at screening

Exclusion Criteria:

  • Taking antiviral treatment for influenza or has a history of using these antivirals within 14 days prior to the administration of study drug
  • Positive influenza B or A+B infection

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: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: CT-P27 90 mg/kg
CT-P27 will be administrated once in IV infusion.
Drug: CT-P27 90 mg/kg
Influenza A treatment drug.
Other Names:
  • CT-P27
EXPERIMENTAL: CT-P27 45mg/kg
CT-P27 will be administrated once in IV infusion.
Drug: CT-P27 45 mg/kg
Influenza A treatment drug.
Other Names:
  • CT-P27
PLACEBO_COMPARATOR: Placebo
Placebo will be administrated once in IV infusion.
Drug: Placebo
Placebo.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Resolution of Influenza Symptoms and Fever
Time Frame: Twice a day (Morning and Evening) from Day 1 to Day 8
Time to resolution of influenza symptoms (cough, sore throat, nasal congestion, headache, feeling feverish, body aches and pains, and fatigue) and fever (<37.8)
Twice a day (Morning and Evening) from Day 1 to Day 8

Collaborators and Investigators

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

Sponsor

Celltrion

Investigators

  • Study Director: MoonSun Choi, 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)

December 9, 2016

Primary Completion (ACTUAL)

March 9, 2018

Study Completion (ACTUAL)

June 15, 2018

Study Registration Dates

First Submitted

February 28, 2018

First Submitted That Met QC Criteria

April 17, 2018

First Posted (ACTUAL)

April 27, 2018

Study Record Updates

Last Update Posted (ACTUAL)

October 31, 2022

Last Update Submitted That Met QC Criteria

October 28, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CT-P27 2.2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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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