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Evaluation of the Protective Efficacy and Safety of CR8020 in an Influenza Challenge

NCT01938352 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2019-04-12

No results posted yet for this study

Summary

After prophylactic vaccination with CR8020, a monoclonal antibody, subjects will be challenged with the H3N2 virus. The protective efficacy, safety, tolerability, pharmacokinetics, and potential immunogenicity will be assessed.

Conditions

Interventions

BIOLOGICAL

CR8020

CR8020 15 mg/kg, administered by intravenous infusion

BIOLOGICAL

Placebo

Placebo (hydrous dextrose in water for injection), administered by intravenous infusion

Sponsors & Collaborators

  • Retroscreen Virology Ltd.

    collaborator INDUSTRY

  • Crucell Holland BV

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-10-02
Primary Completion
2014-01-22
Completion
2014-01-22

Countries

  • United Kingdom

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01938352 on ClinicalTrials.gov