{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,29]],"date-time":"2026-06-29T14:57:22Z","timestamp":1782745042158,"version":"3.54.5"},"reference-count":44,"publisher":"Wiley","issue":"12","license":[{"start":{"date-parts":[[2025,12,21]],"date-time":"2025-12-21T00:00:00Z","timestamp":1766275200000},"content-version":"vor","delay-in-days":20,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["ascpt.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Translational Sci"],"published-print":{"date-parts":[[2025,12]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:p>\n                    Interleukin (IL)\u201013 plays a central role in Type 2 inflammation, contributing to the pathogenesis of atopic dermatitis, asthma, and related inflammatory diseases. APG777 is a novel anti\u2010IL\u201013 monoclonal antibody engineered for improved pharmacokinetics and reduced dosing frequency. This first\u2010in\u2010human, randomized, double\u2010blind, placebo\u2010controlled phase 1 study evaluated the safety, pharmacokinetics, pharmacodynamics, and immunogenicity of single and multiple subcutaneous doses of APG777 in healthy adults. Forty participants were enrolled in single ascending dose (300\u20131200\u2009mg) and multiple dose (300\u2009mg\u2009\u00d7\u20092) cohorts. APG777 was well tolerated, with only mild\u2010to\u2010moderate treatment\u2010emergent adverse events, predominantly unrelated to the study drug. No serious or severe drug\u2010related treatment\u2010emergent adverse events occurred. Following single doses, APG777 exhibited dose\u2010proportional increases in\n                    <jats:italic>C<\/jats:italic>\n                    <jats:sub>max<\/jats:sub>\n                    and area under the curve, with a terminal half\u2010life ranging from 75.3 to 77.5\u2009days across the dose range tested. Immunogenicity was low, with anti\u2010drug antibodies detected in 23.3% of treated participants, generally without impact on pharmacokinetics or safety. APG777 led to rapid and durable inhibition of the IL\u201013\u2010driven biomarkers phosphorylated signal transducer and activator of transcription 6 (pSTAT6), thymus and activation\u2010regulated chemokine (TARC), and immunoglobulin E (IgE), with near\u2010complete suppression of pSTAT6 observed for up to 12\u2009months post\u2010dose. The safety and optimized pharmacokinetic profile of APG777 supports evaluation of extended dosing intervals (every 3\u20136\u2009months) and higher exposures, which could improve outcomes and reduce injection burden in patients with Type 2 inflammatory diseases including atopic dermatitis and asthma.\n                  <\/jats:p>","DOI":"10.1111\/cts.70456","type":"journal-article","created":{"date-parts":[[2025,12,21]],"date-time":"2025-12-21T17:18:24Z","timestamp":1766337504000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["A First\u2010in\u2010Human, Single\u2010 and Multiple\u2010Dose Study of\n                    <scp>APG777<\/scp>\n                    , a Half\u2010Life\u2010Extended Anti\u2010\n                    <scp>IL<\/scp>\n                    \u201013 Monoclonal Antibody, in Healthy Volunteers"],"prefix":"10.1111","volume":"18","author":[{"given":"Xiu Qin","family":"Lim","sequence":"first","affiliation":[{"name":"CMAX Clinical Research  Adelaide Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Erica","family":"Winter","sequence":"additional","affiliation":[{"name":"Apogee Therapeutics, Inc.  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