Pharmacokinetic equivalence of CT-P17 to high-concentration (100 mg/ml) reference adalimumab: A randomized phase I study in healthy subjects.
Adult
Female
Humans
Male
Middle Aged
Young Adult
Adalimumab
/ administration & dosage
Area Under Curve
Biosimilar Pharmaceuticals
/ administration & dosage
Double-Blind Method
Healthy Volunteers
Injections, Subcutaneous
Republic of Korea
Therapeutic Equivalency
Tumor Necrosis Factor Inhibitors
/ administration & dosage
Journal
Clinical and translational science
ISSN: 1752-8062
Titre abrégé: Clin Transl Sci
Pays: United States
ID NLM: 101474067
Informations de publication
Date de publication:
07 2021
07 2021
Historique:
revised:
02
11
2020
received:
29
09
2020
accepted:
09
12
2020
pubmed:
28
1
2021
medline:
15
2
2022
entrez:
27
1
2021
Statut:
ppublish
Résumé
This study aimed to demonstrate pharmacokinetic (PK) equivalence of a single dose of the proposed adalimumab biosimilar CT-P17 to United States-licensed adalimumab (US-adalimumab) and European Union-approved adalimumab (EU-adalimumab). This double-blind, parallel-group, phase I trial (clinicaltrials.gov NCT03970824) was conducted at 10 hospitals (Republic of Korea), in which healthy subjects (1:1:1) were randomized to receive a single 40 mg (100 mg/ml) subcutaneous injection of CT-P17, US-adalimumab, or EU-adalimumab. Primary end points were PK equivalence in terms of: area under the concentration-time curve from time zero to infinity (AUC
Identifiants
pubmed: 33503313
doi: 10.1111/cts.12967
pmc: PMC8301575
doi:
Substances chimiques
Adalimumab
FYS6T7F842
Biosimilar Pharmaceuticals
0
Tumor Necrosis Factor Inhibitors
0
CT-P17
0
Banques de données
ClinicalTrials.gov
['NCT03970824']
Types de publication
Clinical Trial, Phase I
Equivalence Trial
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1280-1291Subventions
Organisme : Celltrion, Inc.
Informations de copyright
© 2021 Celltrion, Inc. Clinical and Translational Science published by Wiley Periodicals LLC on behalf of the American Society for Clinical Pharmacology and Therapeutics.
Références
Pharmacol Res Perspect. 2018 Feb;6(1):
pubmed: 29417761
Front Immunol. 2016 Nov 28;7:508
pubmed: 27965661
Intest Res. 2020 Jan;18(1):34-44
pubmed: 32013313
J Am Acad Dermatol. 2010 Sep;63(3):448-56
pubmed: 20605254
JAMA Intern Med. 2020 Jun 1;180(6):902-903
pubmed: 32227137
BioDrugs. 2020 Apr;34(2):159-170
pubmed: 31792843
Ann Rheum Dis. 2017 Mar;76(3):526-533
pubmed: 27466231
Semin Arthritis Rheum. 2015 Jun;44(6 Suppl):S2-8
pubmed: 26058550
N Engl J Med. 2011 Aug 4;365(5):385-8
pubmed: 21812668
Expert Opin Investig Drugs. 2016 Dec;25(12):1361-1370
pubmed: 27813422
Br J Clin Pharmacol. 2016 Oct;82(4):983-93
pubmed: 27285856
Expert Opin Biol Ther. 2019 Oct;19(10):1075-1083
pubmed: 30698045
Open Access Rheumatol. 2013 May 07;5:43-49
pubmed: 27790023
JAMA Netw Open. 2019 Dec 2;2(12):e1917379
pubmed: 31834391
Br J Clin Pharmacol. 2017 Jul;83(7):1405-1415
pubmed: 28133772
J Clin Pharm Ther. 2017 Dec;42(6):672-678
pubmed: 28675520
RMD Open. 2019 May 21;5(1):e000900
pubmed: 31245050