tetano
Editor, Senior Moderator
Biologicals. 2017 Aug 22. pii: S1045-1056(17)30102-1. doi: 10.1016/j.biologicals.2017.08.007. [Epub ahead of print]
[h=1]A phase 1 study to evaluate the safety and pharmacokinetics of MEDI8852, an anti-influenza A monoclonal antibody, in healthy adult volunteers.[/h] Mallory RM[SUP]1[/SUP], Ali SO[SUP]2[/SUP], Takas T[SUP]3[/SUP], Kankam M[SUP]4[/SUP], Dubovsky F[SUP]5[/SUP], Tseng L[SUP]6[/SUP].
[h=3]Author information[/h]
[h=3]Abstract[/h] MEDI8852 is an IgG1 kappa monoclonal antibody that is being developed to treat patients hospitalized with influenza A. We evaluated the safety and tolerability, pharmacokinetics, and anti-drug antibodies (ADA) of a single intravenous dose of MEDI8852 in healthy adult volunteers (NCT02350751). Forty subjects were randomized to receive either MEDI8852 (250, 750, 1,500, or 3000 mg) (n = 32) or placebo (n = 8) on day 1. Dose escalation was based on cumulative safety data through day 8. Subjects were followed through day 101 for safety, pharmacokinetics, and ADA. Treatment-emergent adverse events (TEAEs) were comparable (37.5%; 37.5%); all TEAEs were mild (grade 1) or moderate (grade 2) in severity. The most frequently reported TEAEs were headache (9.4%, 12.5%) and hypoglycemia (12.5%, 12.5%); all subjects with hypoglycemia were asymptomatic and did not require treatment. No subjects discontinued the study due to a TEAE. Mean area under the curve from time 0 to last sampling time point, area under the curve from time 0 to infinity, and observed maximum concentration for MEDI8852 were dose proportional. The terminal half-life ranged from 19.4 to 22.6 days. No ADAs were detected. A population pharmacokinetic model demonstrated good concentration separation between the 750- and 3000-mg dose groups.
Copyright ? 2017 International Alliance for Biological Standardization. Published by Elsevier Ltd. All rights reserved.
[h=4]KEYWORDS:[/h] Hemagglutinin; Influenza; MEDI8852; Monoclonal antibody
PMID: 28844541 DOI: 10.1016/j.biologicals.2017.08.007
[h=1]A phase 1 study to evaluate the safety and pharmacokinetics of MEDI8852, an anti-influenza A monoclonal antibody, in healthy adult volunteers.[/h] Mallory RM[SUP]1[/SUP], Ali SO[SUP]2[/SUP], Takas T[SUP]3[/SUP], Kankam M[SUP]4[/SUP], Dubovsky F[SUP]5[/SUP], Tseng L[SUP]6[/SUP].
[h=3]Author information[/h]
[h=3]Abstract[/h] MEDI8852 is an IgG1 kappa monoclonal antibody that is being developed to treat patients hospitalized with influenza A. We evaluated the safety and tolerability, pharmacokinetics, and anti-drug antibodies (ADA) of a single intravenous dose of MEDI8852 in healthy adult volunteers (NCT02350751). Forty subjects were randomized to receive either MEDI8852 (250, 750, 1,500, or 3000 mg) (n = 32) or placebo (n = 8) on day 1. Dose escalation was based on cumulative safety data through day 8. Subjects were followed through day 101 for safety, pharmacokinetics, and ADA. Treatment-emergent adverse events (TEAEs) were comparable (37.5%; 37.5%); all TEAEs were mild (grade 1) or moderate (grade 2) in severity. The most frequently reported TEAEs were headache (9.4%, 12.5%) and hypoglycemia (12.5%, 12.5%); all subjects with hypoglycemia were asymptomatic and did not require treatment. No subjects discontinued the study due to a TEAE. Mean area under the curve from time 0 to last sampling time point, area under the curve from time 0 to infinity, and observed maximum concentration for MEDI8852 were dose proportional. The terminal half-life ranged from 19.4 to 22.6 days. No ADAs were detected. A population pharmacokinetic model demonstrated good concentration separation between the 750- and 3000-mg dose groups.
Copyright ? 2017 International Alliance for Biological Standardization. Published by Elsevier Ltd. All rights reserved.
[h=4]KEYWORDS:[/h] Hemagglutinin; Influenza; MEDI8852; Monoclonal antibody
PMID: 28844541 DOI: 10.1016/j.biologicals.2017.08.007