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In this randomized, double\u2010blind, placebo\u2010controlled, single\u2010dose escalation phase I trial, we evaluated the safety, tolerability, pharmacokinetics, and pharmacodynamics of SHR\u20101819 in healthy subjects. Subjects received a single subcutaneous injection of SHR\u20101819 or placebo, with dose escalation starting at 60\u2009mg and subsequently increasing to 120, 240, 360, and 720\u2009mg. A total of 42 eligible subjects were randomized, and 33 received SHR\u20101819 (1 subject in the 60\u2009mg cohort and 8 subjects each in the 120, 240, 360\u2009, and 720\u2009mg cohorts) and 9 received placebo. SHR\u20101819 was well\u2010tolerated, with the majority of adverse events being mild in severity. The exposure of SHR\u20101819 increased in a manner greater than proportionally with a dose range of 120 to 720\u2009mg. The median <jats:italic>T<\/jats:italic><jats:sub>max<\/jats:sub> was within 4\u20137\u2009days (60\u2013720\u2009mg), and the mean half\u2010life ranged from 2.88 to 5.97\u2009days (120\u2013720\u2009mg). The clearance rate of SHR\u20101819 exhibited a decrease with increasing dose level. Administration of SHR\u20101819 resulted in a certain degree of reduction in the percentage change from baseline in concentrations of inflammatory biomarkers TARC\/CCL17 and IgE, while the reduction of TARC\/CCL17 concentrations showed a dose\u2010dependent trend. More than half of the total subjects treated with SHR\u20101819 were reported antidrug antibody\u2010negative. The preliminary data from this phase I study support further development of SHR\u20101819 for the treatment of type 2 inflammatory diseases.<\/jats:p>","DOI":"10.1111\/cts.13763","type":"journal-article","created":{"date-parts":[[2024,3,28]],"date-time":"2024-03-28T09:44:57Z","timestamp":1711619097000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Safety, pharmacokinetics, and pharmacodynamics of <scp>anti\u2010IL\u20104R\u03b1<\/scp> antibody <scp>SHR<\/scp>\u20101819 in healthy subjects: A randomized, controlled phase I study"],"prefix":"10.1111","volume":"17","author":[{"ORCID":"https:\/\/orcid.org\/0009-0001-9511-2384","authenticated-orcid":false,"given":"Na","family":"Li","sequence":"first","affiliation":[{"name":"Jiangsu Hengrui Pharmaceuticals Co., Ltd.  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