{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,23]],"date-time":"2026-08-23T02:04:21Z","timestamp":1787450661824,"version":"build-2736575974"},"reference-count":26,"publisher":"Wiley","issue":"8","license":[{"start":{"date-parts":[[2026,7,26]],"date-time":"2026-07-26T00:00:00Z","timestamp":1785024000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2026,7,26]],"date-time":"2026-07-26T00:00:00Z","timestamp":1785024000000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"funder":[{"DOI":"10.13039\/501100025313","name":"Ferring Pharmaceuticals Netherlands","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100025313","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["ascpt.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Translational Sci"],"published-print":{"date-parts":[[2026,8]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:p>The first\u2010in\u2010class, fully human fusion protein, olamkicept, selectively inhibits trans interleukin\u20106 signaling. Previously, the safety, tolerability, pharmacokinetics (PK), and immunogenicity of olamkicept following single ascending doses (SAD) up to 750\u2009mg and multiple ascending doses (MAD) up to 600\u2009mg daily were assessed. To assess higher doses, parallel trials of olamkicept up to 2400\u2009mg daily were separately performed in healthy European and Japanese adult men. In this phase I, single\u2010center, within\u2010group randomized, double\u2010blind trial, Japanese participants were randomized to SAD olamkicept infusions (1200, 1800, and 2400\u2009mg) or placebo. The primary objective was to assess the safety of higher doses of olamkicept based on treatment\u2010emergent adverse events (TEAEs), vital signs, electrocardiograms (ECG), and clinical chemistry. PK parameters were included as secondary outcomes. Immunogenicity was not assessed in the present Japanese cohort. Twenty\u2010four participants were randomized. Four TEAEs and no adverse drug reactions were reported. All TEAEs were mild and resolved without intervention. There were no treatment or dose related trends in TEAEs, vital signs, ECG, clinical chemistry, hematology, hemostasis, or urinalysis. A single infusion of olamkicept achieved measurable serum concentrations for up to 28\u2009days after treatment and exposure was dose proportional. In conclusion, single doses of olamkicept up to 2400\u2009mg have a favorable safety profile and dose proportional PK in healthy Japanese men.<\/jats:p>\n                  <jats:p>\n                    <jats:bold>Trial Registration:<\/jats:bold>\n                    <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"https:\/\/clinicaltrials.gov\/study\/NCT06515834\">ClinicalTrials.gov<\/jats:ext-link>\n                    identifier: NCT06515834\n                  <\/jats:p>","DOI":"10.1111\/cts.70673","type":"journal-article","created":{"date-parts":[[2026,7,26]],"date-time":"2026-07-26T14:06:41Z","timestamp":1785074801000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Safety and Pharmacokinetics of Olamkicept Doses up to 2400\u2009mg in Healthy Japanese Men: Phase I, Randomized, Placebo\u2010Controlled, and Double\u2010Blind Trial"],"prefix":"10.1111","volume":"19","author":[{"given":"Ryuzo","family":"Hanada","sequence":"first","affiliation":[{"name":"SOUSEIKAI Sumida Hospital  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0003-4350-8074","authenticated-orcid":false,"given":"Katharina","family":"Bruzelius","sequence":"additional","affiliation":[{"name":"Ferring Pharmaceuticals, International PharmaScience Center  Kastrup Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Falkenberg","sequence":"additional","affiliation":[{"name":"Ferring Pharmaceuticals, International PharmaScience Center  Kastrup Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lars\u2010Erik","family":"Kyhl","sequence":"additional","affiliation":[{"name":"Ferring Pharmaceuticals, International PharmaScience Center  Kastrup Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Signe","family":"M\u00f8gelmose","sequence":"additional","affiliation":[{"name":"Ferring Pharmaceuticals, International PharmaScience Center  Kastrup Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0009-0124-1010","authenticated-orcid":false,"given":"Arjun","family":"Ravi","sequence":"additional","affiliation":[{"name":"Ferring Pharmaceuticals, International PharmaScience Center  Kastrup Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4227-7687","authenticated-orcid":false,"given":"Philippe","family":"Pinton","sequence":"additional","affiliation":[{"name":"Ferring Pharmaceuticals, International PharmaScience Center  Kastrup Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Naomichi","family":"Yoneshima","sequence":"additional","affiliation":[{"name":"Ferring Pharmaceuticals Co. 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