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Diabetes, Metabolic Syndrome and Obesity Volume 16, 2023 - Issue
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STUDY PROTOCOL

Randomized, Double-Blind, Placebo-Controlled, Phase I, Dose- Escalation Study to Evaluate the Tolerance, Pharmacokinetics, Pharmacodynamics and Immunogenicity of PEGylated Urate Oxidase for Injection in Healthy Adults and Hyperuricemia Volunteers: Study Protocol

Feifei Sun1 Clinical Trials Center, The Affiliated Hospital of Qingdao University, Qingdao, Shandong, People’s Republic of ChinaORCID Iconhttps://orcid.org/0000-0002-8161-536XView further author information
ORCID Icon,
Chenjing Wang1 Clinical Trials Center, The Affiliated Hospital of Qingdao University, Qingdao, Shandong, People’s Republic of ChinaView further author information
,
Yi Xu1 Clinical Trials Center, The Affiliated Hospital of Qingdao University, Qingdao, Shandong, People’s Republic of ChinaView further author information
,
Pingping Lin1 Clinical Trials Center, The Affiliated Hospital of Qingdao University, Qingdao, Shandong, People’s Republic of ChinaView further author information
,
Yaozhong Cao2 Clinical Medical Center, Xiuzheng Pharmaceutical Group, Hangzhou, Zhejiang, People’s Republic of ChinaView further author information
,
Jiahui Zhang3 Xiuzheng Bio-Medicine Research Institute, Hangzhou, Zhejiang, People’s Republic of ChinaView further author information
,
Xin Li1 Clinical Trials Center, The Affiliated Hospital of Qingdao University, Qingdao, Shandong, People’s Republic of ChinaView further author information
,
Xin Jiang1 Clinical Trials Center, The Affiliated Hospital of Qingdao University, Qingdao, Shandong, People’s Republic of ChinaView further author information
,
Yao Fu1 Clinical Trials Center, The Affiliated Hospital of Qingdao University, Qingdao, Shandong, People’s Republic of ChinaView further author information
&
Yu Cao1 Clinical Trials Center, The Affiliated Hospital of Qingdao University, Qingdao, Shandong, People’s Republic of ChinaCorrespondence[email protected]
ORCID Iconhttps://orcid.org/0000-0002-3980-8133View further author information
ORCID Icon show all
Pages 4263-4268 | Received 10 Aug 2023, Accepted 19 Dec 2023, Published online: 28 Dec 2023

References

  • Zhu Y, Pandya BJ, Choi HK. Comorbidities of gout and hyperuricemia in the US general population: NHANES 2007–2008. Am J Med. 2012;125(7):679–687.e1. doi:10.1016/j.amjmed.2011.09.033
  • Edwards NL, Sundy JS, Forsythe A, Blume S, Pan F, Becker MA. Work productivity loss due to flares in patients with chronic gout refractory to conventional therapy. J Med Econ. 2011;14(1):10–15. doi:10.3111/13696998.2010.540874
  • Guttmann A, Krasnokutsky S, Pillinger MH, Berhanu A. Pegloticase in gout treatment - safety issues, latest evidence and clinical considerations. Ther Adv Drug Saf. 2017;8(12):379–388. doi:10.1177/2042098617727714
  • Tan PK, Farrar JE, Gaucher EA, Miner JN. Coevolution of URAT1 and uricase during primate evolution: implications for serum urate homeostasis and gout. Mol Biol Evol. 2016;33(9):2193–2200. doi:10.1093/molbev/msw116
  • Kanbay M, Jensen T, Solak Y, et al. Uric acid in metabolic syndrome: from an innocent bystander to a central player. Eur J Intern Med. 2016;29:3–8. doi:10.1016/j.ejim.2015.11.026
  • Yanai H, Adachi H, Hakoshima M, Katsuyama H. Molecular biological and clinical understanding of the pathophysiology and treatments of hyperuricemia and its association with metabolic syndrome, cardiovascular diseases and chronic kidney disease. Int J Mol Sci. 2021;22(17):9221. doi:10.3390/ijms22179221
  • Towiwat P, Chhana A, Dalbeth N. The anatomical pathology of gout: a systematic literature review. BMC Musculoskelet Disord. 2019;20(1):140. doi:10.1186/s12891-019-2519-y
  • Schlesinger N, Yasothan U, Kirkpatrick P. Pegloticase. Nat Rev Drug Discov. 2011;10(1):17–18. Erratum in: Nat Rev Drug Discov. 2011 Feb;10(2):156. doi:10.1038/nrd3349
  • Sherman MR, Saifer MGP, Perez-Ruiz F. PEG-uricase in the management of treatment-resistant gout and hyperuricemia. Adv Drug Deliv Rev. 2008;60(1):59–68. doi:10.1016/j.addr.2007.06.011
  • Schlesinger N, Lipsky PE. Pegloticase treatment of chronic refractory gout: update on efficacy and safety. Semin Arthritis Rheum. 2020;50(3S):S31–S38. doi:10.1016/j.semarthrit.2020.04.011
  • Krystexxa prescribing information; 2012. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125293s034lbl.pdf. Accessed December 22, 2023.
  • World Medical A. World medical association declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA. 2013;310(20):2191–2194. doi:10.1001/jama.2013.281053
  • Takezawa M. Good clinical practice (GCP) in clinical trials. Nihon Yakurigaku Zasshi. 2011;138(5):205–208. doi:10.1254/fpj.138.205

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