Abstract：
This study aimed to compare the pharmacokinetics, safety, and immunogenicity of the prefilled syringe (PFS) with lyophilized (LYO) recombinant human tumor necrosis factor-α receptor II:lgG Fc fusion protein (rhTNFR:Fc) in healthy Chinese male subjects. A single-center, randomized, open-label, 2-period, crossover study was performed in healthy Chinese male subjects. Subjects were randomly assigned into 2 sequences and received a subcutaneous injection of 25 mg rhTNFR:Fc PFS or rhTNFR:Fc LYO (Anbainuo), with a 35-day washout between the 2 periods. Blood samples were collected at specified time intervals, and then serum concentrations of rhTNFR:Fc were analyzed by enzyme-linked immunosorbent assay. The maximum serum concentration, area under the concentration-time curve (AUC) from time 0 to the last quantifiable concentration, and AUC from time 0 to infinity were all calculated and evaluated. Meanwhile, safety and immunogenicity were also assessed. A total of 82 subjects completed the study, and six subjects withdrew for various reasons. The 90%CIs for geometric mean ratios of maximum serum concentration, AUC from time 0 to the last quantifiable concentration, and AUC from time 0 to infinity were all within the equivalence range of 80% to 125%. Safety was comparable between the 2 formulations with low immunogenicity. rhTNFR:Fc PFS exhibited similar pharmacokinetic and safety profiles of rhTNFR:Fc LYO (Anbainuo) in healthy Chinese male subjects.
摘要：
本研究旨在比较药代动力学，安全,和具有冻干（LYO）重组人肿瘤坏死因子-α受体II：IgGFc融合蛋白（rhTNFR：Fc）的预填充注射器（PFS）在健康中国男性受试者中的免疫原性。单中心,随机化，开放标签，2期，交叉研究是在健康的中国男性受试者中进行的。受试者被随机分为2个序列，并接受皮下注射25mgrhTNFR：FcPFS或rhTNFR：FcLYO（Anbainuo），在两个时期之间进行35天的冲洗。在指定的时间间隔收集血样，然后通过酶联免疫吸附试验分析rhTNFR:Fc的血清浓度。最大血清浓度,从时间0到最后可量化浓度的浓度-时间曲线下面积（AUC），和从时间0到无穷大的AUC都被计算和评估。同时,还评估了安全性和免疫原性.共有82名受试者完成了这项研究，六个受试者因各种原因退出。最大血清浓度的几何平均比率为90CI，从时间0到最后一个可量化浓度的AUC，从时间0到无穷大的AUC都在80%到125%的等效范围内。具有低免疫原性的2种制剂之间的安全性是相当的。rhTNFR:FcPFS在健康中国男性受试者中表现出rhTNFR:FcLYO(Anbainuo)的相似的药代动力学和安全性特征。
