Pharmacokinetic Profiles of a Proposed Biosimilar Ustekinumab (BFI-751): Results From a Randomized Phase 1 Trial.
BFI-751
NS0
biosimilar
pharmacokinetics
ustekinumab
Journal
Clinical pharmacology in drug development
ISSN: 2160-7648
Titre abrégé: Clin Pharmacol Drug Dev
Pays: United States
ID NLM: 101572899
Informations de publication
Date de publication:
10 2023
10 2023
Historique:
received:
30
01
2023
accepted:
26
06
2023
medline:
4
10
2023
pubmed:
24
7
2023
entrez:
24
7
2023
Statut:
ppublish
Résumé
BioFactura has developed a proposed biosimilar candidate (BFI-751) to ustekinumab reference product. Results are reported for the first-in-human trial designed to compare the pharmacokinetic profiles, safety, and immunogenicity of BFI-751 and ustekinumab reference products from the European Union and United States as well as similarity of the EU and US reference products. This was a multicenter, randomized, double blind, 3-parallel-group study (trial ID: NCT04843631). Healthy subjects were randomized to receive a single subcutaneous dose of 45 mg of BFI-751, EU ustekinumab, or US ustekinumab. The pharmacokinetic parameters were area under the concentration-time curve (AUC) from time zero to infinity, AUC from time zero to the last quantifiable concentration, and maximum concentration. Safety, tolerability, and immunogenicity data were also reported. Pairwise comparisons among the 3 treatments all met the standard bioequivalence criteria that the 90% confidence interval of the geometric mean ratios of AUC from time zero to infinity, AUC from time zero to the last quantifiable concentration, and maximum concentration are completely within the acceptance interval of 80%-125%. There were no marked differences in the safety and tolerability profiles for subjects receiving BFI-751 as compared to EU or US ustekinumab. Treatment-emergent adverse events were mild to moderate for all treatment groups.
Substances chimiques
Ustekinumab
FU77B4U5Z0
Biosimilar Pharmaceuticals
0
Banques de données
ClinicalTrials.gov
['NCT04843631']
Types de publication
Randomized Controlled Trial
Multicenter Study
Clinical Trial, Phase I
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1001-1012Informations de copyright
© 2023, The American College of Clinical Pharmacology.
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