{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,9]],"date-time":"2026-09-09T09:09:22Z","timestamp":1788944962631,"version":"build-2803163510"},"reference-count":19,"publisher":"Wiley","license":[{"start":{"date-parts":[[2026,9,9]],"date-time":"2026-09-09T00:00:00Z","timestamp":1788912000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2026,9,9]],"date-time":"2026-09-09T00:00:00Z","timestamp":1788912000000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["ascpt.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clin Pharma and Therapeutics"],"abstract":"<jats:p>Siltartoxatug, a first\u2010in\u2010class monoclonal antibody targeting tetanus toxin for post\u2010exposure prophylaxis, was evaluated in two phase I trials in Australian and Chinese healthy adults. In these randomized, double\u2010blind, placebo\u2010controlled, dose\u2010escalation studies, participants received a single intramuscular injection of siltartoxatug (10\u2013250\u2009\u03bcg\/kg) or placebo. The primary objectives were to assess safety, with secondary goals evaluating pharmacokinetics (PK) and immunogenicity, and pharmacodynamics (PD) as an exploratory. Siltartoxatug demonstrated an excellent safety profile across all doses, with adverse event (AE) rates comparable to placebo and no serious adverse events (SAE) attributed to the drug. PK analysis revealed dose\u2010proportional exposure, and the PK profile exhibited characteristics typical of an IgG1 monoclonal antibody. PK parameters were highly consistent between Australian and Chinese trials, indicating no apparent ethnic differences in drug disposition. A single dose rapidly induced protective anti\u2010tetanus antibody titers (\u2265\u20090.01\u2009IU\/mL), with all participants in the 100 and 250\u2009\u03bcg\/kg cohorts achieving seroprotection within 48\u2009hours post\u2010dose; 100% seroprotection was sustained through 105\u2009days in the 250\u2009\u03bcg\/kg cohort, and remained high (\u2265\u200983.3%) through Day 85 in the 100\u2009\u03bcg\/kg cohort. Immunogenicity was minimal. These findings collectively highlighted siltartoxatug's potential as a next\u2010generation passive immunizing agent. The consistent PK\/PD profiles between Australian and Chinese populations suggested no apparent ethnic differences, providing a foundation for extrapolating efficacy findings from the Chinese trials to other racial groups.<\/jats:p>","DOI":"10.1002\/cpt.70467","type":"journal-article","created":{"date-parts":[[2026,9,9]],"date-time":"2026-09-09T08:49:08Z","timestamp":1788943748000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Phase I Evaluation of Siltartoxatug, a First\u2010in\u2010Class Anti\u2010Tetanus Monoclonal Antibody: Safety, Pharmacokinetics and Pharmacodynamics in Healthy Australian and Chinese Populations"],"prefix":"10.1002","author":[{"ORCID":"https:\/\/orcid.org\/0009-0007-3026-7610","authenticated-orcid":false,"given":"Xinyu","family":"Liu","sequence":"first","affiliation":[{"name":"Zhuhai Trinomab Pharmaceutical Co., Ltd.  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Zhuhai China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0001-3908-5238","authenticated-orcid":false,"given":"Xiaoyi","family":"Liu","sequence":"additional","affiliation":[{"name":"Zhuhai Trinomab Pharmaceutical Co., Ltd.  Zhuhai China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0006-4441-1188","authenticated-orcid":false,"given":"Jiyuan","family":"Ding","sequence":"additional","affiliation":[{"name":"Zhuhai Trinomab Pharmaceutical Co., Ltd.  Zhuhai China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0009-9569-7173","authenticated-orcid":false,"given":"Xia","family":"Zhou","sequence":"additional","affiliation":[{"name":"Zhuhai Trinomab Pharmaceutical Co., Ltd.  Zhuhai China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0872-5420","authenticated-orcid":false,"given":"Xin","family":"Zhou","sequence":"additional","affiliation":[{"name":"Zhuhai Trinomab Pharmaceutical Co., Ltd.  Zhuhai China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0005-2647-5180","authenticated-orcid":false,"given":"Qianyu","family":"Liang","sequence":"additional","affiliation":[{"name":"Zhuhai Trinomab Pharmaceutical Co., Ltd.  Zhuhai China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0003-1827-232X","authenticated-orcid":false,"given":"Meizhuo","family":"Zhang","sequence":"additional","affiliation":[{"name":"Zhuhai Trinomab Pharmaceutical Co., Ltd.  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