{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,30]],"date-time":"2026-09-30T04:57:32Z","timestamp":1790744252806,"version":"4.1.0"},"reference-count":33,"publisher":"Wiley","issue":"10","license":[{"start":{"date-parts":[[2026,9,29]],"date-time":"2026-09-29T00:00:00Z","timestamp":1790640000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"},{"start":{"date-parts":[[2026,9,29]],"date-time":"2026-09-29T00:00:00Z","timestamp":1790640000000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"funder":[{"DOI":"10.13039\/100000016","name":"U.S. Department of Health and Human Services","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100000016","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100021704","name":"Administration for Strategic Preparedness and Response","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100021704","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100012399","name":"Biomedical Advanced Research and Development Authority","doi-asserted-by":"publisher","award":["HHSO100201700020C"],"award-info":[{"award-number":["HHSO100201700020C"]}],"id":[{"id":"10.13039\/100012399","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["accp1.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Pharm in Drug Dev"],"published-print":{"date-parts":[[2026,10]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>REGN17092, a fully human immunoglobulin (Ig) G1 antibody with M252Y\/S254T\/T256E (YTE) modification in the Fc portion, was assessed in a first\u2010in\u2010human study (ClinicalTrials.gov, NCT05923424). REGN17092 was designed to target the severe acute respiratory coronavirus 2 (SARS\u2010CoV\u20102) S protein. However, due to the emergence of new SARS\u2010CoV\u20102 variants, the program was discontinued. In this single\u2010center, randomized, placebo\u2010controlled, single\u2010ascending\u2010dose study, participants received a single IV dose of REGN17092 (300, 1200, or 2400\u00a0mg) or placebo, or a single SC dose of REGN17092 (300 or 1200) or placebo. Endpoints assessed included pharmacokinetics (PK), safety, and immunogenicity. Allometric scaling was used to predict the terminal half\u2010life of REGN17092 and to ensure adequate exposure multiples relative to the exposure at the NOAEL. Forty participants were included. Mean concentrations of REGN17092 in serum increased in a dose\u2010proportional manner and were consistent with linear PK for a single dose administered IV or SC. PK analysis of a single dose of REGN17092 administered IV or SC suggests that REGN17092 has a half\u2010life of 80\u201390 days and showed detectable penetration into nasal fluid. No anti\u2010drug antibody responses were noted. In this Phase 1 study, REGN17092 was tolerable with a long half\u2010life, highlighting the value of YTE modification.<\/jats:p>","DOI":"10.1002\/cpdd.70107","type":"journal-article","created":{"date-parts":[[2026,9,30]],"date-time":"2026-09-30T04:21:27Z","timestamp":1790742087000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Pharmacokinetics, Immunogenicity, and Safety of a Modified YTE Antibody in Healthy Adults"],"prefix":"10.1002","volume":"15","author":[{"given":"Maria","family":"Rosario","sequence":"first","affiliation":[{"name":"Regeneron Pharmaceuticals, Inc.  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AZD7442 (tixagevimab\/cilgavimab) in healthy Chinese adults","volume":"14","author":"Li N","year":"2025","journal-title":"Clin Pharmacol Drug Dev"}],"container-title":["Clinical Pharmacology in Drug 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