A phase 1, randomized, open-label, single-dose study to assess the relative bioavailability of a subcutaneous dose of FKB327 when administered using a prefilled syringe, a prefilled auto-injector, or a vial with disposable syringe in healthy subjects.
Adalimumab
/ administration & dosage
Adolescent
Adult
Area Under Curve
Biological Availability
Biosimilar Pharmaceuticals
/ administration & dosage
Drug-Related Side Effects and Adverse Reactions
/ epidemiology
Female
Healthy Volunteers
Humans
Incidence
Injections, Subcutaneous
Male
Middle Aged
Syringes
Therapeutic Equivalency
Young Adult
Adalimumab
Biosimilar
Immunogenicity
Pharmacokinetics
Safety
Journal
BMC pharmacology & toxicology
ISSN: 2050-6511
Titre abrégé: BMC Pharmacol Toxicol
Pays: England
ID NLM: 101590449
Informations de publication
Date de publication:
30 12 2019
30 12 2019
Historique:
received:
23
07
2019
accepted:
04
12
2019
entrez:
1
1
2020
pubmed:
1
1
2020
medline:
28
5
2020
Statut:
epublish
Résumé
FKB327 is a biosimilar of the adalimumab reference product (RP). The primary objective was to assess the relative bioavailability of FKB327 after a single subcutaneous (SC) dose via prefilled syringe (PFS), auto-injector (AI), or vial with a disposable syringe (vial), in healthy subjects. This randomized, open-label, parallel-group, single SC-dose study was conducted in 195 healthy male and female subjects who were randomized 1:1:1 to receive FKB327 40 mg via PFS, AI, or vial. The primary pharmacokinetic (PK) parameters, areas under the serum concentration-time curve to the last detectable value (AUC The mean serum FKB327 concentration-time profiles appeared similar across all 3 presentations. AUC Among all 3 delivery methods, PK characteristics, safety profiles, and immunogenicity were similar. EU Clinical Trials Registry EudraCTN2014-004469-26, registered October 14, 2014.
Sections du résumé
BACKGROUND/OBJECTIVE
FKB327 is a biosimilar of the adalimumab reference product (RP). The primary objective was to assess the relative bioavailability of FKB327 after a single subcutaneous (SC) dose via prefilled syringe (PFS), auto-injector (AI), or vial with a disposable syringe (vial), in healthy subjects.
METHODS
This randomized, open-label, parallel-group, single SC-dose study was conducted in 195 healthy male and female subjects who were randomized 1:1:1 to receive FKB327 40 mg via PFS, AI, or vial. The primary pharmacokinetic (PK) parameters, areas under the serum concentration-time curve to the last detectable value (AUC
RESULTS
The mean serum FKB327 concentration-time profiles appeared similar across all 3 presentations. AUC
CONCLUSION
Among all 3 delivery methods, PK characteristics, safety profiles, and immunogenicity were similar.
TRIAL REGISTRATION
EU Clinical Trials Registry EudraCTN2014-004469-26, registered October 14, 2014.
Identifiants
pubmed: 31888742
doi: 10.1186/s40360-019-0376-9
pii: 10.1186/s40360-019-0376-9
pmc: PMC6937755
doi:
Substances chimiques
Biosimilar Pharmaceuticals
0
Adalimumab
FYS6T7F842
Banques de données
EudraCT
['EudraCTN2014-004469-26']
Types de publication
Clinical Trial, Phase I
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
87Références
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pubmed: 26766293