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Cited by 366Monoclonal and Polyclonal Antibodies ResearchRespiratory viral infections researchBiosimilars and Bioanalytical Methods

The DOI matches its Crossref record; 17 of the 18 references it cites were found in a registry or an index.

A Novel Investigational Fc-Modified Humanized Monoclonal Antibody, Motavizumab-YTE, Has an Extended Half-Life in Healthy Adults

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Robbie, Gabriel J., Criste, Ryan, Dall'Acqua, William F., Jensen, Kathryn, Patel, Nita K., Losonsky, Genevieve A., Griffin, M. Pamela·2013·Antimicrobial Agents and Chemotherapy
DOI 10.1128/aac.01285-13PMC PMC3837853
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Abstract

The study objective was to evaluate the pharmacokinetics (PK), antidrug antibody (ADA), and safety of motavizumab-YTE (motavizumab with amino acid substitutions M252Y/S254T/T256E [YTE]), an Fc-modified anti-respiratory syncytial virus (RSV) monoclonal antibody. Healthy adults ( n = 31) were randomized to receive a single intravenous (i.v.) dose of motavizumab-YTE or motavizumab (0.3, 3, 15, or 30 mg/kg) and followed for 240 days. Clearance of motavizumab-YTE was significantly lower (71% to 86%) and the half-life ( t 1/2 ) was 2- to 4-fold longer than with motavizumab. However, similar peak concentrations and volume-of-distribution values, indicative of similar distribution properties, were seen at all dose levels. The sustained serum concentrations of motavizumab-YTE were fully functional, as shown by RSV neutralizing activity that persisted for 240 days with motavizumab-YTE versus 90 days postdose for motavizumab. Safety and incidence of ADA were comparable between groups. In this first study of an Fc-modified monoclonal antibody in humans, motavizumab-YTE was well tolerated and exhibited an extended half-life of up to 100 days. (This study has been registered at ClinicalTrials.gov under registration no. NCT00578682.)

Overview

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Crossref · 10.1128/aac.01285-13

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Citations

Cites

Research works printed but not linked: 2

  1. FaggioniR YaoZ LiangM SchneiderA VainshteinI LeeR RoskosL. 2010. Effect of the YTE mutation on the PK/PD of MEDI5117, abstr T2091. Abstr. Am. Assoc. Pharm. Sci. Natl. Biotechnol. Conf., San Francisco, CA, 17 to 19 May 2010. American Association of Pharmaceutical Scientists, Arlington, VA.
  2. YuX IciekL CristeR SellmanB StoverC JafriH EsserM RoskosL RobbieG. 2013. Modeling of pharmacokinetics (PK) of a YTE-monoclonal antibody targeting Staphylococcus aureus alpha toxin in cynomolgus monkeys: human PK prediction, abstr T2123. Abstr. Am. Assoc. Pharm. Sci. Natl. Biotechnol. Conf., San Francisco, CA, 17 to 19 May 2010. American Association of Pharmaceutical Scientists, Arlington, VA.

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Metadata

Authors
Robbie, G. J., Criste, R., Dall'Acqua, W. F., Jensen, K., Patel, N. K., Losonsky, G. A., & Griffin, M. P.
Affiliations
  • Clinical Pharmacology and DMPK, MedImmune, Gaithersburg, Maryland, USA
  • Antibody Discovery and Protein Engineering, MedImmune, Gaithersburg, Maryland, USA
  • Biostatistics, MedImmune, Gaithersburg, Maryland, USA
  • Research and Development, Infectious Disease, MedImmune, Gaithersburg, Maryland, USA
  • Clinical Research and Development, MedImmune, Gaithersburg, Maryland, USA
ORCID
Venue
Antimicrobial Agents and Chemotherapy
Publisher
American Society for Microbiology
Published
2013-12
Volume
57
Issue
12
Pages
6147-6153
ISSN
  • 0066-4804 (ISSN-L)
  • 1098-6596
DOI
10.1128/aac.01285-13
PMC
PMC3837853
OpenAlex
W2148090354
Cited by
366
References
18
Citations by year
2026: 31 · 2025: 26 · 2024: 33 · 2023: 37 · 2022: 47 · 2021: 22 · 2020: 20 · 2019: 26 · 2018: 26 · 2017: 38 · 2016: 19 · 2015: 25 · 2014: 14 · 2013: 1
FWCI
15.26
Type
journal article
Language
en
Open access
Licence
journals.asm.org/non-commercial-tdm-license (tdm)
Locations
  • Antimicrobial Agents and Chemotherapy (publishedVersion)
  • Europe PMC (PubMed Central) (publishedVersion)
  • PubMed Central (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Life Sciences › Immunology and Microbiology › Immunology › Monoclonal and Polyclonal Antibodies Research
  • Health Sciences › Medicine › Epidemiology › Respiratory viral infections research
  • Life Sciences › Immunology and Microbiology › Immunology › Biosimilars and Bioanalytical Methods
Keywords
respiratory syncytial virus, pharmacokinetics, extended half-life, clearance, amino acid substitutions, antidrug antibodies, drug safety, healthy volunteers
MeSH terms
Adult, Antiviral Agents, Double-Blind Method, Female, Half-Life, Humans, Immunoglobulin Fc Fragments, Injections, Intravenous, Male, Metabolic Clearance Rate, Drugs, Investigational, Antibodies, Monoclonal, Humanized

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