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

Celltrion Healthcare

Status and phase: Completed; Phase 2

Conditions: Influenza A

Treatments: Drug: CT-P27; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02071914

CT-P27 2.1

Details and patient eligibility

About

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

Full 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.

Enrollment: 81 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy Male & Female volunteers

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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81 participants in 3 patient groups, including a placebo group

CT-P27 10mg/kg

Experimental group

Description:

CT-P27 will be administrated once in IV infusion.

Treatment:

Drug: CT-P27

CT-P27 20mg/kg

Experimental group

Description:

CT-P27 will be administrated once in IV infusion.

Treatment:

Drug: CT-P27

Placebo

Placebo Comparator group

Description:

Placebo will be administrated once in IV infusion.

Treatment:

Drug: Placebo