627. A Phase 1 Study to Evaluate the Safety and Pharmacokinetics of MEDI8852 in Healthy Adults
Session: Poster Abstract Session: Oh, Those Pesky Viruses!
Thursday, October 27, 2016
Room: Poster Hall
Posters
  • Mallory et al 2016_IDSA.pdf (3.6 MB)
  • Background: Influenza is responsible for significant morbidity and mortality and more effective therapeutics are needed. MEDI8852 is a human immunoglobulin G1 (IgG1) kappa monoclonal antibody (mAb) that binds to the conserved stalk region of the influenza hemagglutinin protein and can neutralize seasonal as well as pandemic influenza A strains. MEDI8852 is being developed to treat patients hospitalized with type A influenza. The primary objective of the present study was to evaluate the safety and pharmacokinetics (PK) of MEDI8852.

    Methods: Healthy subjects aged 18 to 65 years were enrolled in this study. Subjects were randomized to receive a single intravenous (IV) dose of either MEDI8852 or placebo on Day 1. Dose escalation was based on review of Day 8 safety data. Subjects were followed through Day 29 for adverse events (AEs), and through Day 101 for serious AEs (SAEs), PK, and antidrug antibodies (ADAs) against MEDI8852.

    Results: A total of 40 subjects (32 MEDI8852 and 8 placebo) were enrolled and the mean (standard deviation) age was 36.3 (14.2) years. Adverse events were comparable across treatment groups (MEDI8852, 37.5%; placebo, 37.5%); all were Grade 1 or 2 in severity. The most frequently reported AEs were headache (MEDI8852, 3/32 [9.4%] subjects; placebo, 1/8 [12.5%] subjects) and hypoglycaemia (MEDI8852, 4/32 [12.5%] subjects; placebo, 1/8 [12.5%] subjects). The AEs were not dose-dependent. There were no SAEs or deaths. MEDI8852 PK was linear with dose-proportional increases in serum MEDI8852 concentrations. The terminal elimination half-life was 19.4 to 22.6 days. No ADAs were detected.

    Conclusion: The results demonstrate that a single-dose IV infusion with MEDI8852 was safe and well tolerated in healthy adults, and exhibited a PK profile similar to that of a typical IgG1 Ab. The data support the continued development of MEDI8852 for the treatment of influenza A infected patients.

    Raburn Mallory, MD1, Martin K. Kankam, MD, PhD, MPH2, Song Ren, PhD3, Omar Ali, PhD1, Therese Takas, BS4, Yun Chen, PhD5, Filip Dubovsky, MD1 and Leo Tseng, PhD6, (1)Clinical Development, MedImmune, Gaithersburg, MD, (2)Internal Medicine and Epidemiology, Vince and Associates Clinical Research, Overland Park, KS, (3)Global Medicines Development, AstraZeneca, Gaithersburg, MD, (4)Clinical Operations, MedImmune, Gaithersburg, MD, (5)Biostatistics, MedImmune, Gaithersburg, MD, (6)Drug Metabolism and Pharmacokinetics, MedImmune, Mountain View, CA

    Disclosures:

    R. Mallory, MedImmune: Employee , Salary

    M. K. Kankam, MedImmune: Investigator , Investigator Payments

    S. Ren, MedImmune: Employee , Salary

    O. Ali, MedImmune: Employee , Salary

    T. Takas, MedImmune: Employee , Salary

    Y. Chen, MedImmune: Employee , Salary

    F. Dubovsky, MedImmune: Employee , Salary

    L. Tseng, MedImmune: Employee , Salary

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