{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,29]],"date-time":"2026-10-29T08:36:24Z","timestamp":1793262984651,"version":"4.5.0"},"reference-count":17,"publisher":"Elsevier BV","issue":"11","license":[{"start":{"date-parts":[[2026,11,1]],"date-time":"2026-11-01T00:00:00Z","timestamp":1793491200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/tdm\/userlicense\/1.0\/"},{"start":{"date-parts":[[2026,11,1]],"date-time":"2026-11-01T00:00:00Z","timestamp":1793491200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/legal\/tdmrep-license"},{"start":{"date-parts":[[2026,9,28]],"date-time":"2026-09-28T00:00:00Z","timestamp":1790553600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100004325","name":"AstraZeneca","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004325","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["clinicalkey.com","clinicalkey.com.au","clinicalkey.es","clinicalkey.fr","clinicalkey.jp","jiac-j.com","elsevier.com","sciencedirect.com"],"crossmark-restriction":true},"short-container-title":["Journal of Infection and Chemotherapy"],"published-print":{"date-parts":[[2026,11]]},"DOI":"10.1016\/j.jiac.2026.103078","type":"journal-article","created":{"date-parts":[[2026,9,19]],"date-time":"2026-09-19T23:34:23Z","timestamp":1789860863000},"page":"103078","update-policy":"https:\/\/doi.org\/10.1016\/elsevier_cm_policy","source":"Crossref","is-referenced-by-count":0,"title":["A phase 1, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of sipavibart in healthy Japanese adults"],"prefix":"10.1016","volume":"32","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4985-5432","authenticated-orcid":false,"given":"Hiroshi","family":"Okada","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0000-3382-6325","authenticated-orcid":false,"given":"Takumi","family":"Shinbo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hyosung","family":"Kim","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yoshinori","family":"Noda","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takashi","family":"Eto","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"78","reference":[{"key":"10.1016\/j.jiac.2026.103078_bib1","series-title":"Our world in data. Japan: coronavirus pandemic country profile","year":"2025"},{"key":"10.1016\/j.jiac.2026.103078_bib2","doi-asserted-by":"crossref","DOI":"10.2807\/1560-7917.ES.2020.25.48.2000895","article-title":"Clinical characteristics and risk factors associated with severe COVID-19: prospective analysis of 1,045 hospitalised cases in North-Eastern France, march 2020","volume":"25","author":"Kaeuffer","year":"2020","journal-title":"Euro Surveill"},{"key":"10.1016\/j.jiac.2026.103078_bib3","doi-asserted-by":"crossref","DOI":"10.1016\/j.jiac.2025.102840","article-title":"The continued impact of COVID-19 during the omicron era on immunocompromised individuals in Japan","volume":"31","author":"Taniguchi","year":"2025","journal-title":"J Infect Chemother"},{"key":"10.1016\/j.jiac.2026.103078_bib4","doi-asserted-by":"crossref","first-page":"3","DOI":"10.1038\/s41580-021-00418-x","article-title":"Mechanisms of SARS-CoV-2 entry into cells","volume":"23","author":"Jackson","year":"2022","journal-title":"Nat Rev Mol Cell Biol"},{"key":"10.1016\/j.jiac.2026.103078_bib5","doi-asserted-by":"crossref","first-page":"1049","DOI":"10.1007\/s40265-025-02186-w","article-title":"Sipavibart: first approval","volume":"85","author":"Keam","year":"2025","journal-title":"Drugs"},{"key":"10.1016\/j.jiac.2026.103078_bib6","doi-asserted-by":"crossref","DOI":"10.1126\/scitranslmed.ado2817","article-title":"AZD3152 neutralizes SARS-CoV-2 historical and contemporary variants and is protective in hamsters and well tolerated in adults","volume":"16","author":"Cai","year":"2024","journal-title":"Sci Transl Med"},{"key":"10.1016\/j.jiac.2026.103078_bib7","doi-asserted-by":"crossref","first-page":"813","DOI":"10.1016\/S1473-3099(24)00804-1","article-title":"Efficacy and safety of sipavibart for prevention of COVID-19 in individuals who are immunocompromised (SUPERNOVA): a randomised, controlled, double-blind, phase 3 trial","volume":"25","author":"Haidar","year":"2025","journal-title":"Lancet Infect Dis"},{"key":"10.1016\/j.jiac.2026.103078_bib8","series-title":"AdisInsight. Sipavibart - AstraZeneca","year":"2025"},{"key":"10.1016\/j.jiac.2026.103078_bib10","doi-asserted-by":"crossref","first-page":"540","DOI":"10.1111\/cts.12567","article-title":"Tutorial on monoclonal antibody pharmacokinetics and its considerations in early development","volume":"11","author":"Ovacik","year":"2018","journal-title":"Clin Transl Sci"},{"key":"10.1016\/j.jiac.2026.103078_bib11","series-title":"Kavigale - summary of product characteristics","year":"2024"},{"key":"10.1016\/j.jiac.2026.103078_bib12","doi-asserted-by":"crossref","DOI":"10.1002\/cti2.1517","article-title":"Serum AZD7442 (tixagevimab-cilgavimab) concentrations and in vitro IC50 values predict SARS-CoV-2 neutralising antibody titres","volume":"13","author":"Clegg","year":"2024","journal-title":"Clin Transl Immunol"},{"key":"10.1016\/j.jiac.2026.103078_bib13","doi-asserted-by":"crossref","DOI":"10.1093\/infdis\/jiag269","article-title":"Serum virus-neutralizing antibody titers in clinical trial participants with and without immunocompromise receiving pemivibart, a long-acting monoclonal antibody for COVID-19","author":"Narayan","year":"2026","journal-title":"J Infect Dis"},{"key":"10.1016\/j.jiac.2026.103078_bib14","doi-asserted-by":"crossref","DOI":"10.1080\/19420862.2022.2153410","article-title":"Antibodies to watch in 2023","volume":"15","author":"Kaplon","year":"2023","journal-title":"mAbs"},{"key":"10.1016\/j.jiac.2026.103078_bib15","year":"2024","journal-title":"List of new drugs"},{"key":"10.1016\/j.jiac.2026.103078_bib16","doi-asserted-by":"crossref","DOI":"10.1016\/j.jiac.2024.07.007","article-title":"Clinical characteristics and COVID-19-related outcomes of immunocompromised patients receiving tixagevimab\/cilgavimab pre-exposure prophylaxis in Japan","volume":"31","author":"Taniguchi","year":"2025","journal-title":"J Infect Chemother"},{"key":"10.1016\/j.jiac.2026.103078_bib17","doi-asserted-by":"crossref","DOI":"10.1016\/j.jiac.2024.12.006","article-title":"Real-world experience of tixagevimab\/cilgavimab prophylaxis in Japanese patients with immunodeficiency","volume":"31","author":"Inoue","year":"2025","journal-title":"J Infect Chemother"},{"key":"10.1016\/j.jiac.2026.103078_bib18","doi-asserted-by":"crossref","first-page":"e400","DOI":"10.1097\/INF.0000000000004936","article-title":"Current challenges and future directions for RSV prevention strategies in Japan","volume":"44","author":"Ogimi","year":"2025","journal-title":"Pediatr Infect Dis J"}],"container-title":["Journal of Infection and Chemotherapy"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S1341321X26001765?httpAccept=text\/xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S1341321X26001765?httpAccept=text\/plain","content-type":"text\/plain","content-version":"vor","intended-application":"text-mining"}],"deposited":{"date-parts":[[2026,10,29]],"date-time":"2026-10-29T08:13:19Z","timestamp":1793261599000},"score":1,"resource":{"primary":{"URL":"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S1341321X26001765"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,11]]},"references-count":17,"journal-issue":{"issue":"11","published-print":{"date-parts":[[2026,11]]}},"alternative-id":["S1341321X26001765"],"URL":"https:\/\/doi.org\/10.1016\/j.jiac.2026.103078","relation":{},"ISSN":["1341-321X"],"issn-type":[{"value":"1341-321X","type":"print"}],"subject":[],"published":{"date-parts":[[2026,11]]},"assertion":[{"value":"Elsevier","name":"publisher","label":"This article is maintained by"},{"value":"A phase 1, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of sipavibart in healthy Japanese adults","name":"articletitle","label":"Article Title"},{"value":"Journal of Infection and Chemotherapy","name":"journaltitle","label":"Journal Title"},{"value":"https:\/\/doi.org\/10.1016\/j.jiac.2026.103078","name":"articlelink","label":"CrossRef DOI link to publisher maintained version"},{"value":"article","name":"content_type","label":"Content Type"},{"value":"\u00a9 2026 Japanese Society of Chemotherapy, Japanese Association for Infectious Diseases, and Japanese Society for Infection Prevention and Control. Published by Elsevier Ltd. All rights are reserved, including those for text and data mining, AI training, and similar technologies.","name":"copyright","label":"Copyright"}],"article-number":"103078"}}