Pharmacokinetic equivalence of CT-P17 to high-concentration (100 mg/ml) reference adalimumab: A randomized phase I study in healthy subjects
- Abstract
- 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(0-inf)); AUC from time zero to the last quantifiable concentration (AUC(0-last)); and maximum serum concentration (C-max). PK equivalence was concluded if 90% confidence intervals (CIs) for percent ratios of geometric least squares means (GLSMs) for pairwise comparisons were within the equivalence margin of 80-125%. Additional PK end points, safety, and immunogenicity were evaluated. Of the 312 subjects who were randomized (103 CT-P17; 103 US-adalimumab; 106 EU-adalimumab), 308 subjects received study drug. AUC(0-inf), AUC(0-last), and C-max were equivalent among CT-P17, US-adalimumab, and EU-adalimumab, because 90% CIs for the ratios of GLSMs were within the 80-125% equivalence margin for each pairwise comparison. Secondary PK end points, safety, and immunogenicity were similar between treatment groups. In conclusion, PK equivalence for single-dose administration of CT-P17, EU-adalimumab, and US-adalimumab was demonstrated in healthy adults. Safety and immunogenicity profiles were comparable between treatment groups and consistent with previous reports for adalimumab biosimilars.
- Author(s)
- 유경상; 장인진; 임형석; 홍장희; 김민걸; 박민규; 조두연; 박민수; 정재용; 김종률; 이승환; 윤석규; 권인선; 이상준; 김성현; 배윤주; 차정빈; Daniel E Furst; Edward Keystone; Jonathan Kay
- Issued Date
- 2021
- Type
- Article
- Keyword
- Adalimumab; Analysis; Clinical trials; Research
- DOI
- 10.1111/cts.12967
- URI
- https://oak.ulsan.ac.kr/handle/2021.oak/7694
https://ulsan-primo.hosted.exlibrisgroup.com/primo-explore/fulldisplay?docid=TN_cdi_doaj_primary_oai_doaj_org_article_7d507bd001904a1aa34884f6d604a326&context=PC&vid=ULSAN&lang=ko_KR&search_scope=default_scope&adaptor=primo_central_multiple_fe&tab=default_tab&query=any,contains,Pharmacokinetic%20equivalence%20of%20CT-P17%20to%20high-concentration%20(100%20mg%2Fml)%20reference%20adalimumab:%20A%20randomized%20phase%20I%20study%20in%20healthy%20subjects&offset=0&pcAvailability=true
- Publisher
- CTS-CLINICAL AND TRANSLATIONAL SCIENCE
- Location
- 미국
- Language
- 영어
- ISSN
- 1752-8054
- Citation Volume
- 14
- Citation Number
- 4
- Citation Start Page
- 1280
- Citation End Page
- 1291
-
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- Medicine > Medicine
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