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In a single ascending dose trial (N\u2009=\u200956), participants received subcutaneous MK-6194 or placebo (3:1 ratio) across dose levels ranging from 1 to 10\u2009mg. In a multiple ascending dose trial (N\u2009=\u200954), participants received subcutaneous MK-6194 or placebo (3:1 ratio) at dose levels ranging from 0.5 to 5\u2009mg every 2\u2009wk (total 3 doses) as well as 5\u2009mg every 4\u2009wk (total 2 doses). Baseline characteristics were comparable between trials, with participants mostly male with a mean age of 36\u2009yr. There were no serious adverse events or dose-limiting toxicities. The most common adverse events were injection site erythema and eosinophil count elevations (with no indication of severe eosinophilia or eosinophilia-related organ damage). PK showed dose-proportionality and repeated doses of MK-6194 did not result in accumulation or time-dependent PK. Immunogenicity was low with no impact on PK or safety. Treg expansion as assessed by flow cytometry and Treg-specific demethylation region analysis was observed in a dose-dependent manner during both trials and expanded within about 8\u2009d postdose up to about 5-fold and returned to baseline by 14 to 29\u2009d postdose. Minimal impact was observed on other lymphocytes including total T lymphocyte and natural killer cell counts. These findings support the further development of MK-6194 as a potential treatment for autoimmune disorders.<\/jats:p>","DOI":"10.1093\/immhor\/vlaf005","type":"journal-article","created":{"date-parts":[[2025,3,30]],"date-time":"2025-03-30T16:46:47Z","timestamp":1743353207000},"source":"Crossref","is-referenced-by-count":10,"title":["Safety, pharmacokinetics, and pharmacodynamics of MK-6194, an IL-2 mutein designed to selectively activate regulatory T cells: single ascending dose and multiple ascending dose trial data"],"prefix":"10.1093","volume":"9","author":[{"given":"Johannes F","family":"Scheid","sequence":"first","affiliation":[{"name":"Merck & Co., Inc. , Rahway, NJ,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kiki","family":"Cunningham-Bussel","sequence":"additional","affiliation":[{"name":"Merck & Co., Inc. , Rahway, NJ,","place":["United 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