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Co-primary endpoints were area under the serum concentration\u2013time profile (AUC) from time zero extrapolated to infinity (AUC<jats:sub>0\u2013inf<\/jats:sub>) and from zero to last quantifiable concentration (AUC<jats:sub>last<\/jats:sub>). Secondary endpoint was the maximum serum drug concentration (C<jats:sub>max<\/jats:sub>). Study participants were monitored for treatment-emergent adverse events (TEAEs) and samples were collected for anti-drug antibody (ADA) testing throughout the study.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>Pharmacokinetic parameters were similar across groups. The respective geometric least-squares mean ratios (GLSMR) of AUC<jats:sub>0\u2013inf<\/jats:sub>, AUC<jats:sub>last<\/jats:sub> and C<jats:sub>max<\/jats:sub> were: 95.7%, 96.0% and 101.8% for HLX04 versus bevacizumab-US; 94.3%, 94.6% and 100.5% for HLX04 versus bevacizumab-EU; and 90.0%, 90.4% and 98.2% for HLX04 versus bevacizumab-CN. For all test-to-reference comparisons, two-sided 90% confidence intervals of GLSMR for AUC<jats:sub>0\u2013inf<\/jats:sub>, AUC<jats:sub>last<\/jats:sub> and C<jats:sub>max<\/jats:sub> fell in the pre-specified bioequivalence range (80\u2013125%). There were no notable differences in the frequency, nature and\/or grade of TEAEs. No deaths were reported and no ADAs were detected during the study.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusion<\/jats:title>\n                <jats:p>HLX04 had similar safety and pharmacokinetic profiles to reference bevacizumab in healthy Chinese males, supporting the confirmatory Phase 3 study investigating the efficacy and safety equivalence between HLX04 and bevacizumab in patients with metastatic colorectal cancer (NCT03511963).<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Clinical trial registration<\/jats:title>\n                <jats:p>The study was registered with Clinicaltrials.gov, NCT03483649.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1007\/s00280-021-04297-z","type":"journal-article","created":{"date-parts":[[2021,6,4]],"date-time":"2021-06-04T12:02:53Z","timestamp":1622808173000},"page":"465-474","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":11,"title":["A phase 1 randomized study compare the pharmacokinetics, safety and immunogenicity of HLX04 to reference bevacizumab sourced from the United States, the European Union, and China in healthy Chinese male volunteers"],"prefix":"10.1007","volume":"88","author":[{"given":"Xiaoxue","family":"Zhu","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hongjie","family":"Qian","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jixuan","family":"Sun","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Min","family":"Wu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chen","family":"Yu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yanhua","family":"Ding","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiaodi","family":"Zhang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Katherine","family":"Chai","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2936-7864","authenticated-orcid":false,"given":"Xiaojiao","family":"Li","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2021,6,4]]},"reference":[{"issue":"1","key":"4297_CR1","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1111\/j.1365-2710.2007.00800.x","volume":"32","author":"I Kramer","year":"2007","unstructured":"Kramer I, Lipp HP (2007) Bevacizumab, a humanized anti-angiogenic monoclonal antibody for the treatment of colorectal cancer. 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All other authors declare no competing interests.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and\/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval"}},{"value":"All participants provided written informed consent before admission and initiation of the study.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to participate"}}]}}