Pharmacokinetics, Safety, Tolerability, and Immunogenicity of BP02 (Trastuzumab Biosimilar) Compared to EU- and US-Approved Trastuzumab in Healthy Adult Male Volunteers: A Phase 1, Randomized, Double-Blind Study.
BP02
Biosimilar
Herceptin
Pharmacokinetics
Phase 1 study
Trastuzumab
Journal
Oncology and therapy
ISSN: 2366-1089
Titre abrégé: Oncol Ther
Pays: New Zealand
ID NLM: 101677510
Informations de publication
Date de publication:
07 Jul 2024
07 Jul 2024
Historique:
received:
06
05
2024
accepted:
25
06
2024
medline:
7
7
2024
pubmed:
7
7
2024
entrez:
7
7
2024
Statut:
aheadofprint
Résumé
This study evaluated the pharmacokinetic (PK) equivalence between BP02 (a proposed trastuzumab biosimilar) and the reference trastuzumab approved in the EU (EU-trastuzumab) and the US (US-trastuzumab). In this phase 1, double-blind, parallel-group trial, 111 healthy male volunteers were randomized 1:1:1 to receive a single 6-mg/kg intravenous infusion of BP02, EU-trastuzumab, or US-trastuzumab and were evaluated for 78 days. Serum drug concentration-time data were analyzed by non-compartmental methods. The PK similarity of BP02 to the two reference products, and between EU-trastuzumab and US-trastuzumab, was determined using the standard 80-125% bioequivalence criteria. Baseline demographics for the 111 subjects with evaluable pharmacokinetics were similar across all treatment groups. PK profiles were similar for the three products. The 90% confidence intervals (CIs) for the ratios of area under the serum concentration-time curve (AUC) from the time of dosing to infinity (AUC This study demonstrates the PK similarity among BP02, EU-trastuzumab, and US-trastuzumab. The safety and immunogenicity profiles observed for the three products in this study are consistent with previous reports for trastuzumab. ANZCTR number: ACTRN12621000573853.
Identifiants
pubmed: 38972020
doi: 10.1007/s40487-024-00289-0
pii: 10.1007/s40487-024-00289-0
doi:
Banques de données
ANZCTR
['ACTRN12621000573853']
Types de publication
Journal Article
Langues
eng
Informations de copyright
© 2024. The Author(s).
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