Pharmacokinetics and Pharmacodynamics of Bimagrumab (BYM338).
Journal
Clinical pharmacokinetics
ISSN: 1179-1926
Titre abrégé: Clin Pharmacokinet
Pays: Switzerland
ID NLM: 7606849
Informations de publication
Date de publication:
01 2023
01 2023
Historique:
accepted:
01
11
2022
pubmed:
18
12
2022
medline:
8
2
2023
entrez:
17
12
2022
Statut:
ppublish
Résumé
Bimagrumab is a human monoclonal antibody binding to the activin type II receptor with therapeutic potential in conditions of muscle wasting and obesity. This phase I study evaluated the pharmacokinetics (PK), pharmacodynamics (PD), and safety of various dose regimens of bimagrumab and routes of administration in healthy older adults. This was a randomized, double-blind, placebo-controlled, parallel-arm, multiple-dose study in older adult men and women (aged ≥ 70 years, body mass index [BMI] 18-34 kg/m Eighty-four of 91 (92.3%) randomized participants (mean age 74.5 years; BMI 28.0 kg/m Dose levels of bimagrumab administered weekly subcutaneously resulted in PK profiles and PD effects comparable with monthly intravenous dosing, which supports the feasibility of the subcutaneous route of administration for bimagrumab for future clinical development.
Sections du résumé
BACKGROUND
Bimagrumab is a human monoclonal antibody binding to the activin type II receptor with therapeutic potential in conditions of muscle wasting and obesity. This phase I study evaluated the pharmacokinetics (PK), pharmacodynamics (PD), and safety of various dose regimens of bimagrumab and routes of administration in healthy older adults.
METHODS
This was a randomized, double-blind, placebo-controlled, parallel-arm, multiple-dose study in older adult men and women (aged ≥ 70 years, body mass index [BMI] 18-34 kg/m
RESULTS
Eighty-four of 91 (92.3%) randomized participants (mean age 74.5 years; BMI 28.0 kg/m
CONCLUSIONS
Dose levels of bimagrumab administered weekly subcutaneously resulted in PK profiles and PD effects comparable with monthly intravenous dosing, which supports the feasibility of the subcutaneous route of administration for bimagrumab for future clinical development.
Identifiants
pubmed: 36527600
doi: 10.1007/s40262-022-01189-0
pii: 10.1007/s40262-022-01189-0
doi:
Substances chimiques
bimagrumab
N15SW1DIV8
Antibodies, Monoclonal, Humanized
0
Antibodies, Monoclonal
0
Types de publication
Randomized Controlled Trial
Clinical Trial, Phase I
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
141-155Informations de copyright
© 2022. The Author(s), under exclusive licence to Springer Nature Switzerland AG.
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