Preclinical Characterization of ASP2713, a Novel Igβ and FcγRIIB Cross-Linking Antibody, for Prediction of Human Pharmacokinetics and Clinically Effective Dose.
Antibody drug
Immunotherapy
Interspecies (dose) scaling
Mechanistic modeling
Pharmacodynamics
Pharmacokinetic/pharmacodynamic (PK/PD) Correlation
Pharmacokinetics
Receptor
Journal
Journal of pharmaceutical sciences
ISSN: 1520-6017
Titre abrégé: J Pharm Sci
Pays: United States
ID NLM: 2985195R
Informations de publication
Date de publication:
09 2022
09 2022
Historique:
received:
10
02
2022
revised:
07
06
2022
accepted:
07
06
2022
pubmed:
15
6
2022
medline:
23
8
2022
entrez:
14
6
2022
Statut:
ppublish
Résumé
Previously, we reported the fundamental pharmacological characteristics of a novel Igβ and Fc gamma receptor IIB cross-linking antibody, ASP2713, as a new treatment option for systemic lupus erythematosus. The aims of the present study were to investigate ASP2713's characteristics with regard to pharmacological effect, pharmacokinetics (PK), and receptor occupancy, and to predict its human PK and clinically effective dose. The relationship between the concentration and receptor occupancy of ASP2713 for Igβ of B cell receptors was examined using whole blood B cells. Calculated EC
Identifiants
pubmed: 35700799
pii: S0022-3549(22)00250-7
doi: 10.1016/j.xphs.2022.06.006
pii:
doi:
Substances chimiques
Antibodies, Monoclonal
0
Immunoglobulin G
0
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
2630-2638Informations de copyright
Copyright © 2022 American Pharmacists Association. Published by Elsevier Inc. All rights reserved.
Déclaration de conflit d'intérêts
Declaration of Competing Interest Kentaro Konishi, Koji Nakamura, Yuichi Hanada, Yukihiro Kitanaga, Satoshi Kubo, Fumitaka Kinugasa, Daisuke Yamajuku, Masashi Maeda, Nobuchika Yamamoto, Tsuyoshi Minematsu, and Masato Ohbuchi are employees of Astellas Pharma Inc. This study was funded by Astellas Pharma Inc. Medical writing/editing support was provided by Guy Harris of DMC Corp. and funded by Astellas Pharma Inc.