{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,19]],"date-time":"2026-01-19T04:39:03Z","timestamp":1768797543939,"version":"3.49.0"},"reference-count":21,"publisher":"Wiley","issue":"10","license":[{"start":{"date-parts":[[2022,7,23]],"date-time":"2022-07-23T00:00:00Z","timestamp":1658534400000},"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":[[2022,10]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>HDIT101 is a first\u2010in\u2010class humanized monoclonal antibody recognizing a conserved epitope in glycoprotein B, a target present on the surface of herpes simplex virus 1 (HSV\u20101) and HSV\u20102 particles as well as on virus\u2010infected cells. This was a first\u2010in\u2010human, single\u2010center, double\u2010blind, placebo\u2010controlled trial in 24 healthy volunteers, randomized 3:1 (placebo:active) in each of the six dose levels with escalating doses up to 12,150\u2009mg HDIT101. HDIT101 was administered intravenously, to study safety, pharmacokinetics (PKs), and immunogenicity. HDIT101 was well\u2010tolerated in all recipients and no serious or severe adverse events, no infusion\u2010related reactions, and no events suggestive of dose limiting off\u2010target toxicity occurred. The mean serum exposure (area under the curve from zero to infinity [AUC<jats:sub>0\u2010\u221e<\/jats:sub>]) of HDIT101 showed a linear increase from 4340\u2009h*\u03bcg\/ml at a dose of 50\u2009mg to 1,122,247\u2009h*\u03bcg\/ml at a dose of 12,150\u2009mg. No immunogenic effects following HDIT101 exposure were observed at any of the applied doses. HDIT101 demonstrated the expected PK properties of a monoclonal antibody was well\u2010tolerated, and could be safely administered even at excessively high doses that may be required for treatment of patients with septical HSV spread.<\/jats:p>","DOI":"10.1111\/cts.13365","type":"journal-article","created":{"date-parts":[[2022,7,23]],"date-time":"2022-07-23T12:38:02Z","timestamp":1658579882000},"page":"2366-2377","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":10,"title":["First\u2010in\u2010human, randomized, double\u2010blind, placebo\u2010controlled, dose escalation trial of the anti\u2010herpes simplex virus monoclonal antibody <scp>HDIT101<\/scp> in healthy volunteers"],"prefix":"10.1111","volume":"15","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8743-5194","authenticated-orcid":false,"given":"Antje","family":"Blank","sequence":"first","affiliation":[{"name":"Department of Clinical Pharmacology and 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Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Michaela","family":"Arndt","sequence":"additional","affiliation":[{"name":"Heidelberg ImmunoTherapeutics GmbH  Heidelberg Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0672-6876","authenticated-orcid":false,"given":"Walter E.","family":"Haefeli","sequence":"additional","affiliation":[{"name":"Department of Clinical Pharmacology and Pharmacoepidemiology Heidelberg University Hospital  Heidelberg Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"J\u00fcrgen","family":"Krauss","sequence":"additional","affiliation":[{"name":"NCT, National Center for Tumor Diseases, Department of Medical Oncology Heidelberg University Hospital  Heidelberg 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