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Evaluation of the Safety and Efficacy of a Monoclonal Antibody to Treat Influenza

NCT03903718 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2020-01-18

No results posted yet for this study

Summary

The purpose of the study is to evaluate the efficacy and safety of MEDI8852 for the treatment of influenza caused by a wild type A/H1N1 challenge strain in healthy, influenza serosusceptible adults.

Conditions

Interventions

DRUG

Oseltamivir

75 mg capsules orally twice a day from Day 2 to Day 7

BIOLOGICAL

MEDI8852

MEDI8852 is a human IgG1 kappa monoclonal antibody administered as a single IV infusion at either dose 1 or dose 2 on Day 2.

DRUG

Placebo

Placebo is salt-water solution containing no active ingredients and administered as a single IV infusion on Day 2.

Sponsors & Collaborators

  • MedImmune LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-04-03
Primary Completion
2020-10-09
Completion
2020-10-09
FDA Drug
Yes

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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 NCT03903718 on ClinicalTrials.gov