Cited 11 times in
Pharmacokinetic equivalence of CT-P17 to high-concentration (100 mg/ml) reference adalimumab: A randomized phase I study in healthy subjects
DC Field | Value | Language |
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dc.date.accessioned | 2022-11-24T00:39:03Z | - |
dc.date.available | 2022-11-24T00:39:03Z | - |
dc.date.issued | 2021-07 | - |
dc.identifier.issn | 1752-8054 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/190859 | - |
dc.description.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 (AUC0-inf ); AUC from time zero to the last quantifiable concentration (AUC0-last ); and maximum serum concentration (Cmax ). 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. AUC0-inf , AUC0-last , and Cmax 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. | - |
dc.description.statementOfResponsibility | open | - |
dc.language | English | - |
dc.publisher | WileyBlackwell Pub. | - |
dc.relation.isPartOf | Clinical and Translational Science | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.subject.MESH | Adalimumab / administration & dosage | - |
dc.subject.MESH | Adalimumab / adverse effects | - |
dc.subject.MESH | Adalimumab / pharmacokinetics* | - |
dc.subject.MESH | Adult | - |
dc.subject.MESH | Area Under Curve | - |
dc.subject.MESH | Biosimilar Pharmaceuticals / administration & dosage | - |
dc.subject.MESH | Biosimilar Pharmaceuticals / adverse effects | - |
dc.subject.MESH | Biosimilar Pharmaceuticals / pharmacokinetics* | - |
dc.subject.MESH | Double-Blind Method | - |
dc.subject.MESH | Female | - |
dc.subject.MESH | Healthy Volunteers | - |
dc.subject.MESH | Humans | - |
dc.subject.MESH | Injections, Subcutaneous | - |
dc.subject.MESH | Male | - |
dc.subject.MESH | Middle Aged | - |
dc.subject.MESH | Republic of Korea | - |
dc.subject.MESH | Therapeutic Equivalency | - |
dc.subject.MESH | Tumor Necrosis Factor Inhibitors / administration & dosage | - |
dc.subject.MESH | Tumor Necrosis Factor Inhibitors / adverse effects | - |
dc.subject.MESH | Tumor Necrosis Factor Inhibitors / pharmacokinetics* | - |
dc.subject.MESH | Young Adult | - |
dc.title | Pharmacokinetic equivalence of CT-P17 to high-concentration (100 mg/ml) reference adalimumab: A randomized phase I study in healthy subjects | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Others | - |
dc.contributor.googleauthor | Kyung-Sang Yu | - |
dc.contributor.googleauthor | In-Jin Jang | - |
dc.contributor.googleauthor | Hyeong-Seok Lim | - |
dc.contributor.googleauthor | Jang Hee Hong | - |
dc.contributor.googleauthor | Min-Gul Kim | - |
dc.contributor.googleauthor | Min Kyu Park | - |
dc.contributor.googleauthor | Doo-Yeoun Cho | - |
dc.contributor.googleauthor | Min Soo Park | - |
dc.contributor.googleauthor | Jae Yong Chung | - |
dc.contributor.googleauthor | Jong-Lyul Ghim | - |
dc.contributor.googleauthor | SeungHwan Lee | - |
dc.contributor.googleauthor | Seok Kyu Yoon | - |
dc.contributor.googleauthor | In Sun Kwon | - |
dc.contributor.googleauthor | Sang Joon Lee | - |
dc.contributor.googleauthor | Sung Hyun Kim | - |
dc.contributor.googleauthor | Yun Ju Bae | - |
dc.contributor.googleauthor | Jung Bin Cha | - |
dc.contributor.googleauthor | Daniel E Furst | - |
dc.contributor.googleauthor | Edward Keystone | - |
dc.contributor.googleauthor | Jonathan Kay | - |
dc.identifier.doi | 10.1111/cts.12967 | - |
dc.relation.journalcode | J04188 | - |
dc.identifier.eissn | 1752-8062 | - |
dc.identifier.pmid | 33503313 | - |
dc.identifier.url | https://ascpt.onlinelibrary.wiley.com/doi/10.1111/cts.12967 | - |
dc.citation.volume | 14 | - |
dc.citation.number | 4 | - |
dc.citation.startPage | 1280 | - |
dc.citation.endPage | 1291 | - |
dc.identifier.bibliographicCitation | Clinical and Translational Science, Vol.14(4) : 1280-1291, 2021-07 | - |
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