Eur J Clin Pharmacol (2017) 73:1095–1101 DOI 10.1007/s00228-017-2280-9 CLINICAL TRIAL Pharmacokinetics and immunogenicity of T0001, a newly developed anti-TNFα fusion protein, in healthy volunteers 1,2 1,3 4 5 6 1 Yitong Wang & Chang Liu & Shi Chen & Wei Wang & Lihou Dong & Qian Wang & 1 7 8 9 1,2 10 Yan Wang & Libo Zhao & Yannan Zang & Zhenwei Xie & Yang Liu & Yanjun Liu & 6 4 1 Haifeng Song & Zhanguo Li & Yi Fang Received: 6 April 2017 /Accepted: 2 June 2017 /Published online: 21 June 2017 Springer-Verlag GmbH Germany 2017 Abstract dose–exposure proportionality analysis, the estimated points Purpose T0001 was the first mutant of recombinant fusion for AUC and C were 0.87 with a 90% CI of 0.76–0.98 0-∞ max protein of human tumor necrosis factor receptor and Fc frag- and 0.86 with a 90% CI of 0.74–0.97 respectively. The plasma ment (rhTNFR:Fc) based on etanercept on a global scale. This concentration of free (unbound T0001) plasma TNFα and study was carried out to investigate the pharmacokinetics (PK) total (bound and unbound T0001) TNFα both increased sig- and immunogenicity of T0001 in healthy Chinese volunteers. nificantly after the injection
European Journal of Clinical Pharmacology – Springer Journals
Published: Jun 21, 2017
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