{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,27]],"date-time":"2026-05-27T13:26:50Z","timestamp":1779888410317,"version":"3.53.1"},"reference-count":21,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2020,5,28]],"date-time":"2020-05-28T00:00:00Z","timestamp":1590624000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Major New Drugs Innovation and Development","award":["2017ZX09304005"],"award-info":[{"award-number":["2017ZX09304005"]}]},{"name":"Major New Drugs Innovation and Development","award":["2018ZX09736008"],"award-info":[{"award-number":["2018ZX09736008"]}]},{"name":"Science Program of Zhejiang province, China","award":["2017C03003"],"award-info":[{"award-number":["2017C03003"]}]}],"content-domain":{"domain":["accp1.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Pharm in Drug Dev"],"published-print":{"date-parts":[[2021,3]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>A comparison of the immunogenicity, safety, and pharmacokinetic properties of HS016 and its originator, adalimumab, was conducted in Chinese healthy male subjects. This was a phase 1 single\u2010center, randomized, parallel\u2010group double\u2010blind clinical trial. Chinese healthy male subjects (1:1) allocated to HS016 and adalimumab groups were treated with single subcutaneous injections (40\u00a0mg\/0.8\u00a0mL). The pharmacokinetic equivalence of HS016 and adalimumab was assessed by (1) the area under the plasma concentration\u2010time curve (AUC) from time 0 to the last detectable drug concentration (AUC<jats:sub>0\u2010t<\/jats:sub>), (2) the AUC from time 0 extrapolated to infinity (AUC<jats:sub>0\u2010\u221e<\/jats:sub>), and (3) the maximum plasma concentration (C<jats:sub>max<\/jats:sub>). Other pharmacokinetic parameters (time to C<jats:sub>max<\/jats:sub>, apparent clearance, and half\u2010life), safety, and immunogenicity were also evaluated. A total of 136 subjects were randomly divided into HS016 (n = 68) or adalimumab (n = 68) groups. The geometric means of AUC<jats:sub>0\u2010t<\/jats:sub>, AUC<jats:sub>0\u2010\u221e<\/jats:sub>, and C<jats:sub>max<\/jats:sub> were similar for HS016 and adalimumab. The 90%CIs of AUC<jats:sub>0\u2010t<\/jats:sub> (87.2% to 106.1%), AUC<jats:sub>0\u2010\u221e<\/jats:sub> (87.4% to 108.4%), and C<jats:sub>max<\/jats:sub> (98.6% to 113.6%) were all within the prespecified bioequivalence criteria (80% to 125%). The incidence of treatment\u2010emergent adverse events (TEAEs) was similar in both groups, with most TEAEs being mild; only 3 (4.4%) subjects in the HS016 group experienced moderate TEAEs. No significant differences in the time to C<jats:sub>max<\/jats:sub>, apparent clearance, half\u2010life, and immunogenicity were detected. The pharmacokinetic profile of HS016 was equivalent to that of the originator, adalimumab, with similar safety and immunogenicity profiles. HS016 may be considered for assessment in the treatment of patients with ankylosing spondylitis.<\/jats:p>","DOI":"10.1002\/cpdd.816","type":"journal-article","created":{"date-parts":[[2020,5,28]],"date-time":"2020-05-28T15:15:41Z","timestamp":1590678941000},"page":"317-325","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":6,"title":["A Randomized, Double\u2010Blind, Parallel\u2010Group, Phase 1 Clinical Trial Comparing the Pharmacokinetic, Safety, and Immunogenicity of the Biosimilar HS016 and the Originator Adalimumab in Chinese Healthy Male Subjects"],"prefix":"10.1002","volume":"10","author":[{"given":"Guoying","family":"Cao","sequence":"first","affiliation":[{"name":"Phase I Clinical Trial Center Huashan Hospital Fudan University  Shanghai China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jicheng","family":"Yu","sequence":"additional","affiliation":[{"name":"Phase I Clinical Trial Center Huashan 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