Accession Number:

AD1094925

Title:

Phase 1/2a Clinical Trial Study to Evaluate the Efficacy of MEDI8852 in the Treatment of Influenza in Adults Challenged with a Wild-Type Influenza Strain

Descriptive Note:

Technical Report,15 Sep 2018,10 Sep 2019

Corporate Author:

MedImmune, LLC Gaithersburg United States

Personal Author(s):

Report Date:

2019-10-01

Pagination or Media Count:

62.0

Abstract:

MedImmune is developing MEDI8852, a highly potent, broadly-neutralizing, human B cell derived influenza A monoclonal antibody, for treatment of patients hospitalized with type A influenza. MEDI8852 has shown high levels of protection in influenza A lethal murine and ferret models of infections even when administered up to 4 days post infection. MEDI8852 was also more active than oseltamivir, in protecting animals from lethal influenza infection, leading to an extension of the treatment window by 2 to 3 days. In an initial single ascending study conducted in adults with influenza who were not hospitalized, MEDI8852 decreased titers of shed influenza virus and influenza symptoms to the same extent as treatment with oseltamivir. We planned to conduct a randomized, partially-blinded, placebo- and active-controlled challenge study to evaluate the efficacy of MEDI8852 for the treatment of influenza in adults. The primary objective was to assess the impact of MEDI8852 on nasal shedding in adults challenged with a wild-type H1N1 virus. During this reporting period, activities in preparation for the Phase 12a clinical trial have ceased as the contract was terminated effective 10 September 2019.

Subject Categories:

  • Medicine and Medical Research

Distribution Statement:

APPROVED FOR PUBLIC RELEASE