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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

228 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-09

Study Completion Date

2018-06-15

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Influenza A

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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CT-P27 90 mg/kg

CT-P27 will be administrated once in IV infusion.

Group Type EXPERIMENTAL

CT-P27 90 mg/kg

Intervention Type DRUG

Influenza A treatment drug.

CT-P27 45mg/kg

CT-P27 will be administrated once in IV infusion.

Group Type EXPERIMENTAL

CT-P27 45 mg/kg

Intervention Type DRUG

Influenza A treatment drug.

Placebo

Placebo will be administrated once in IV infusion.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo.

Interventions

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CT-P27 90 mg/kg

Influenza A treatment drug.

Intervention Type DRUG

CT-P27 45 mg/kg

Influenza A treatment drug.

Intervention Type DRUG

Placebo

Placebo.

Intervention Type DRUG

Other Intervention Names

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CT-P27 CT-P27

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No