Translational Approach for Predicting Human Pharmacokinetics of Engineered Therapeutic Monoclonal Antibodies with Increased FcRn-Binding Mutations

[11] Tachibana T(2013)A novel investigational Fc-modified humanized monoclonal antibody, motavizumab-YTE, has an extended half-life in healthy adults Antimicrob Agents Chemother 57 e667-142

[12] Maeda A(2019)Safety and pharmacokinetics of broadly neutralising human monoclonal antibody VRC07-523LS in healthy adults: a phase 1 dose-escalation clinical trial Lancet HIV. 6 61-217

[13] Higuchi Y(2011)Projecting human pharmacokinetics of therapeutic antibodies from nonclinical data: what have we learned? MAbs 3 131-814

[14] Shimaoka S(2011)Quantitative prediction of human pharmacokinetics for monoclonal antibodies: retrospective analysis of monkey as a single species for first-in-human prediction Clin Pharmacokinet 50 208-344

[15] Igawa T(2017)Quantitative prediction of therapeutic antibody pharmacokinetics after intravenous and subcutaneous injection in human Drug Metab Pharmacokinet 32 803-566

[16] Haraya K(2021)A monoclonal antibody for malaria prevention N Engl J Med 385 337-343

[17] Hattori K(2020)A double-blind, phase I, single ascending dose study to assess the safety, pharmacokinetics, and pharmacodynamics of BOS161721 in healthy subjects Clin Transl Sci 13 2263-4290

[18] Mimoto F(2022)Safety and serum distribution of anti-SARS-CoV-2 monoclonal antibody MAD0004J08 after intramuscular injection Nat Commun 13 556-760

[19] Tatsumi K(2021)A phase 1 randomized, double-blind, placebo-controlled trial to assess the safety, tolerability, and pharmacokinetics of a respiratory syncytial virus neutralizing monoclonal antibody MK-1654 in healthy adults Clin Pharmacol Drug Dev. 10 331-853

[20] Shimizu S(2015)The neonatal Fc receptor (FcRn) binds independently to both sites of the IgG homodimer with identical affinity MAbs 7 4282-537

[11] Tachibana T(2013)A novel investigational Fc-modified humanized monoclonal antibody, motavizumab-YTE, has an extended half-life in healthy adults Antimicrob Agents Chemother 57 e667-142

[12] Maeda A(2019)Safety and pharmacokinetics of broadly neutralising human monoclonal antibody VRC07-523LS in healthy adults: a phase 1 dose-escalation clinical trial Lancet HIV. 6 61-217

[13] Higuchi Y(2011)Projecting human pharmacokinetics of therapeutic antibodies from nonclinical data: what have we learned? MAbs 3 131-814

[14] Shimaoka S(2011)Quantitative prediction of human pharmacokinetics for monoclonal antibodies: retrospective analysis of monkey as a single species for first-in-human prediction Clin Pharmacokinet 50 208-344

[15] Igawa T(2017)Quantitative prediction of therapeutic antibody pharmacokinetics after intravenous and subcutaneous injection in human Drug Metab Pharmacokinet 32 803-566

[16] Haraya K(2021)A monoclonal antibody for malaria prevention N Engl J Med 385 337-343

[17] Hattori K(2020)A double-blind, phase I, single ascending dose study to assess the safety, pharmacokinetics, and pharmacodynamics of BOS161721 in healthy subjects Clin Transl Sci 13 2263-4290

[18] Mimoto F(2022)Safety and serum distribution of anti-SARS-CoV-2 monoclonal antibody MAD0004J08 after intramuscular injection Nat Commun 13 556-760

[19] Tatsumi K(2021)A phase 1 randomized, double-blind, placebo-controlled trial to assess the safety, tolerability, and pharmacokinetics of a respiratory syncytial virus neutralizing monoclonal antibody MK-1654 in healthy adults Clin Pharmacol Drug Dev. 10 331-853

[20] Shimizu S(2015)The neonatal Fc receptor (FcRn) binds independently to both sites of the IgG homodimer with identical affinity MAbs 7 4282-537