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

International Immunopharmacology(2022)

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摘要
•A randomized controlled clinical study was performed in healthy men.•We compared the PK, safety, and immunogenicity of SCT630 and adalimumab.•SCT630 and adalimumab appeared to have bioequivalent pharmacokinetics.•Treatment-emergent adverse events were observed in both groups.•SCT630 and adalimumab have similar pharmacokinetics and are safe and well tolerated.
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关键词
SCT630 monoclonal antibody injection,Adalimumab,Pharmacokinetic,Biosimilarity,Immunogenicity
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