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.
S. Ren, MedImmune: Employee , Salary
O. Ali, MedImmune: Employee , Salary
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