{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,25]],"date-time":"2026-08-25T13:18:51Z","timestamp":1787663931158,"version":"build-2736575974"},"reference-count":28,"publisher":"Wiley","issue":"8","license":[{"start":{"date-parts":[[2026,8,23]],"date-time":"2026-08-23T00:00:00Z","timestamp":1787443200000},"content-version":"vor","delay-in-days":22,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2026,8,1]],"date-time":"2026-08-01T00:00:00Z","timestamp":1785542400000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["accp1.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Pharm in Drug Dev"],"published-print":{"date-parts":[[2026,8]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>\n                    Plasma gelsolin (pGSN) is a non\u2010immunosuppressive anti\u2010inflammatory immunomodulator with demonstrated efficacy in animal models of acute lung injury. Its therapeutic potential for moderate\u2010to\u2010severe acute respiratory distress syndrome is currently under investigation. This randomized, double\u2010blind, placebo\u2010controlled study assessed the safety, pharmacokinetics, and immunogenicity of multiple ascending doses of recombinant human pGSN (rhu\u2010pGSN) in healthy volunteers. Thirty\u2010two participants were enrolled across four dose cohorts (6, 12, 18, and 24\u00a0mg\/kg of body weight), randomized 3:1 to receive five daily intravenous (IV) infusions of rhu\u2010pGSN or placebo. Plasma pGSN concentrations increased as dose increased after single and multiple IV administrations. Following the final dose, geometric mean C\n                    <jats:sub>max<\/jats:sub>\n                    ranged from 218.9 to 970.9\u00a0\u00b5g\/mL, and geometric mean AUC\n                    <jats:sub>0\u2013inf<\/jats:sub>\n                    ranged from 6634.8 to 17,779.1 h \u00b5g\/mL across four dose levels. Ten subjects (41.7%) who received rhu\u2010pGSN reported a total of 13 adverse events (AEs), and one subject (12.5%) who received placebo reported an AE. All AEs were mild or moderate. No anti\u2010rhu\u2010pGSN antibodies were detected pre\u2010dose or at Day 28 post first dose. Overall, five IV rhu\u2010pGSN doses (up to 24\u00a0mg\/kg daily) appeared safe and well tolerated.\n                  <\/jats:p>","DOI":"10.1002\/cpdd.70094","type":"journal-article","created":{"date-parts":[[2026,8,24]],"date-time":"2026-08-24T06:35:20Z","timestamp":1787553320000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["A Phase 1, Single\u2010Center, Randomized, Double\u2010Blind, Placebo\u2010Controlled, Multiple\u2010Dose Escalation Study for the Evaluation of the Safety, Tolerability, and Pharmacokinetics of Recombinant Human Plasma Gelsolin (rhu\u2010pGSN) Following Intravenous Administration to Healthy Volunteers"],"prefix":"10.1002","volume":"15","author":[{"given":"Yao","family":"Liu","sequence":"first","affiliation":[{"name":"BioAegis Therapeutics North Brunswick  NJ USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Susan 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