Phase I, randomized, double-blind, single-dose study to assess the pharmacokinetics, safety, and immunogenicity of the proposed biosimilar SCT630 and adalimumab in healthy Chinese subjects

Author:

Liu Long,Qi Lu,Lei Chunpu,Wang Yu,Zhang Wei,Liu Ying,Li Pu,Bai Haihong,Li Yan,Li Yinjuan,Liu Ju,Xie Liangzhi,Wang Xinghe

Publisher

Elsevier BV

Subject

Pharmacology,Immunology,Immunology and Allergy

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3. Humira label, 2020. https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125057s415lbl.pdf/ (Accessed 11 March 2020), U.S. Food and Drug Administration.

4. A randomised, single-blind, single-dose, three-arm, parallel-group study in healthy subjects to demonstrate pharmacokinetic equivalence of ABP 501 and adalimumab;Kaur;Ann. Rheum. Dis.,2017

5. Predictors of dose escalation of adalimumab in a prospective cohort of Crohn’s disease patients;Bultman;Aliment. Pharmacol. Ther.,2012

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