{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,7,30]],"date-time":"2025-07-30T12:29:01Z","timestamp":1753878541150,"version":"3.41.2"},"reference-count":28,"publisher":"Wiley","issue":"10","license":[{"start":{"date-parts":[[2024,10,1]],"date-time":"2024-10-01T00:00:00Z","timestamp":1727740800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["ascpt.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Translational Sci"],"published-print":{"date-parts":[[2024,10]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>CT\u2010P13, a biosimilar of infliximab, is used to treat inflammatory diseases that arise from immune system complications, resulting in excessive and persistent inflammation. The subcutaneous (SC) formulation of CT\u2010P13 overcomes the drawback of prolonged administration associated with the intravenous (IV) infliximab biosimilar, necessitating autoinjector (AI) administration. This randomized, open\u2010label, two\u2010arm, parallel\u2010group, single\u2010dose clinical pharmacology study aimed to evaluate the pharmacokinetics (PK) and safety of CT\u2010P13 SC administration via AI compared with the existing pre\u2010filled syringe (PFS) method. A total of 147 healthy participants were randomized into two groups, of which 139 completed the study. Blood samples were collected from before CT\u2010P13 SC administration to 2016\u2009h after the start of the administration. Serum concentrations were analyzed using the Meso Scale Discovery electrochemiluminescence method. Geometric mean ratios (90% confidence interval) of the AUC<jats:sub>inf<\/jats:sub> (areas under the concentration\u2013time curve from zero to infinity) and <jats:italic>C<\/jats:italic><jats:sub>max<\/jats:sub> (The maximum serum concentration) for CT\u2010P13 SC AI versus CT\u2010P13 SC PFS groups, were 94.15% (85.02%\u2013104.26%), 92.48% (84.66%\u2013101.01%), respectively. CT\u2010P13 SC AI and CT\u2010P13 SC PFS achieved comparable PK because the 90% CI was within the predefined equivalence margin. At the end of the study, immunogenicity results revealed that 70 (97.22%) and 73 (98.65%) participants tested positive for anti\u2010drug antibody (ADA) in the CT\u2010P13 SC AI and CT\u2010P13 SC PFS groups, respectively. They were tested positive for neutralizing antibodies. No other significant safety differences were observed between the treatment groups. In conclusion, both administrations demonstrated PK equivalence and were both safe and well\u2010tolerated.<\/jats:p>","DOI":"10.1111\/cts.70037","type":"journal-article","created":{"date-parts":[[2024,10,1]],"date-time":"2024-10-01T09:59:59Z","timestamp":1727776799000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Pharmacokinetic comparison of subcutaneously administered <scp>CT<\/scp>\u2010<scp>P13<\/scp> (biosimilar of infliximab) via autoinjector and pre\u2010filled syringe in healthy participants"],"prefix":"10.1111","volume":"17","author":[{"ORCID":"https:\/\/orcid.org\/0009-0007-2762-7742","authenticated-orcid":false,"given":"Ye Chan","family":"Park","sequence":"first","affiliation":[{"name":"Clinical Trials Center Chungnam National University Hospital  Daejeon Korea"},{"name":"Department of Medical Science Chungnam National University College of Medicine  Daejeon Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5643-0913","authenticated-orcid":false,"given":"Jae Hoon","family":"Kim","sequence":"additional","affiliation":[{"name":"Clinical Trials Center Chungnam National University Hospital  Daejeon Korea"},{"name":"Department of Medical Science Chungnam National University College of Medicine  Daejeon Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sung Hyun","family":"Kim","sequence":"additional","affiliation":[{"name":"Medical Science Division Celltrion, Inc.  Incheon Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0009-0008-4152-8545","authenticated-orcid":false,"given":"Ju Hyun","family":"Lee","sequence":"additional","affiliation":[{"name":"Medical Science Division Celltrion, Inc.  Incheon Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0623-5455","authenticated-orcid":false,"given":"Jang Hee","family":"Hong","sequence":"additional","affiliation":[{"name":"Clinical Trials Center Chungnam National University Hospital  Daejeon Korea"},{"name":"Department of Pharmacology Chungnam National University College of Medicine  Daejeon Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2591-4867","authenticated-orcid":false,"given":"Jin\u2010Gyu","family":"Jung","sequence":"additional","affiliation":[{"name":"Department of Family Medicine Chungnam National University Hospital  Daejeon Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8801-0323","authenticated-orcid":false,"given":"Jung","family":"Sunwoo","sequence":"additional","affiliation":[{"name":"Clinical Trials Center Chungnam National University Hospital  Daejeon Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2024,10]]},"reference":[{"key":"e_1_2_9_2_1","unstructured":"Global Autoimmune Institute.Autoimmune VS autoinflammatory disease: a comparative look. 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