Pharmacokinetics and safety of candidate tocilizumab biosimilar CT-P47 versus reference tocilizumab: a randomized, double-blind, single-dose phase I study
DC Field | Value | Language |
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dc.contributor.author | Yu, Kyung-Sang | - |
dc.contributor.author | Kim, Byungwook | - |
dc.contributor.author | Shin, Dongseong | - |
dc.contributor.author | Park, Min Kyu | - |
dc.contributor.author | Hwang, Jun Gi | - |
dc.contributor.author | Kim, Min-Gul | - |
dc.contributor.author | Chung, Hyewon | - |
dc.contributor.author | Ghim, JongLyul | - |
dc.contributor.author | Chung, Jae-Yong | - |
dc.contributor.author | Smolen, Josef S. | - |
dc.contributor.author | Burmester, Gerd R. | - |
dc.contributor.author | Kim, SungHyun | - |
dc.contributor.author | Bae, YunJu | - |
dc.contributor.author | Jeon, DaBee | - |
dc.contributor.author | Yoo, JaeKyoung | - |
dc.contributor.author | Yang, GoEun | - |
dc.contributor.author | Bae, JiHun | - |
dc.contributor.author | Keystone, Edward | - |
dc.date.accessioned | 2023-07-06T00:40:28Z | - |
dc.date.available | 2023-07-06T00:40:28Z | - |
dc.date.created | 2023-06-15 | - |
dc.date.issued | 2023-05 | - |
dc.identifier.issn | 1354-3784 | - |
dc.identifier.uri | https://scholarworks.bwise.kr/gachon/handle/2020.sw.gachon/88379 | - |
dc.description.abstract | Background: CT-P47 is a candidate tocilizumab biosimilar. This study assessed the pharmacokinetic (PK) equivalence of CT-P47 and European Union-approved reference tocilizumab (EU-tocilizumab) in healthy Asian adults.Research design and methods: This double-blind, multicenter, parallel-group trial randomized healthy adults (1:1) to receive a single (162 mg/0.9 mL) subcutaneous dose of CT-P47 or EU-tocilizumab. The primary endpoint (Part 2) was PK equivalence by area under the concentration - time curve (AUC) from time zero to last quantifiable concentration (AUC(0-last)), AUC from time zero to infinity (AUC(0-inf)), and maximum serum concentration (C-max). PK equivalence was concluded if 90% confidence intervals (CIs) for the ratios of geometric least-squares means (gLSMs) were within the 80-125% equivalence margin. Additional PK endpoints, immunogenicity, and safety were evaluated.Results: In Part 2, 289 participants were randomized (146 CT-P47; 143 EU-tocilizumab); 284 received study drug. AUC(0-last), AUC(0-inf), and C-max were equivalent between CT-P47 and EU-tocilizumab: 90% CIs for the ratios of gLSMs were within the 80-125% equivalence margin. Secondary PK endpoints, immunogenicity, and safety were comparable between groups.Conclusions: CT-P47 demonstrated PK equivalence with EU-tocilizumab and was well tolerated, following a single dose in healthy adults. | - |
dc.language | 영어 | - |
dc.language.iso | en | - |
dc.publisher | TAYLOR & FRANCIS LTD | - |
dc.relation.isPartOf | EXPERT OPINION ON INVESTIGATIONAL DRUGS | - |
dc.title | Pharmacokinetics and safety of candidate tocilizumab biosimilar CT-P47 versus reference tocilizumab: a randomized, double-blind, single-dose phase I study | - |
dc.type | Article | - |
dc.type.rims | ART | - |
dc.description.journalClass | 1 | - |
dc.identifier.wosid | 000995821100001 | - |
dc.identifier.doi | 10.1080/13543784.2023.2212155 | - |
dc.identifier.bibliographicCitation | EXPERT OPINION ON INVESTIGATIONAL DRUGS, v.32, no.5, pp.429 - 439 | - |
dc.description.isOpenAccess | Y | - |
dc.identifier.scopusid | 2-s2.0-85160679454 | - |
dc.citation.endPage | 439 | - |
dc.citation.startPage | 429 | - |
dc.citation.title | EXPERT OPINION ON INVESTIGATIONAL DRUGS | - |
dc.citation.volume | 32 | - |
dc.citation.number | 5 | - |
dc.contributor.affiliatedAuthor | Shin, Dongseong | - |
dc.type.docType | Article | - |
dc.subject.keywordAuthor | Biosimilar | - |
dc.subject.keywordAuthor | CT-P47 | - |
dc.subject.keywordAuthor | immunogenicity | - |
dc.subject.keywordAuthor | pharmacokinetics | - |
dc.subject.keywordAuthor | safety | - |
dc.subject.keywordAuthor | tocilizumab | - |
dc.subject.keywordPlus | PHARMACODYNAMICS | - |
dc.relation.journalResearchArea | Pharmacology & Pharmacy | - |
dc.relation.journalWebOfScienceCategory | Pharmacology & Pharmacy | - |
dc.description.journalRegisteredClass | scie | - |
dc.description.journalRegisteredClass | scopus | - |
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