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

Phase 2CompletedNCT02071914

Celltrion81 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Influenza A

Interventions

CT-P27DRUG

Influenza A treatment drug.

PlaceboDRUG

Placebo.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy Male \& Female volunteers Exclusion Criteria: * Current clinically significant disease * Pregnant or nursing mother * Abnormal pulmonary function, nose or nasopharynx

Locations (1)

Retroscreen Virology Ltd.

London, United Kingdom

Outcomes

Primary Outcomes

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

Time frame: Three times a day from Day 1(the day after virus inoculation) to Day 9

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.