多中心、随机、双盲、平行对照重组人源抗TNF-α单克隆抗体注射液与修美乐在类风湿关节炎患者中Ⅲ期临床研究
[Translation] A multicenter, randomized, double-blind, parallel controlled phase III clinical study of recombinant human anti-TNF-α monoclonal antibody injection and Humira in patients with rheumatoid arthritis
主要评价重组人源抗TNF-α单克隆抗体注射液与修美乐在中重度活动性类风湿关节炎患者中的疗效相似性;次要评价重组人源抗TNF-α单克隆抗体注射液与修美乐在中重度活动性类风湿关节炎患者中的药代动力学特征、安全性和免疫原性
[Translation] The primary purpose is to evaluate the similarity of the efficacy of recombinant human anti-TNF-α monoclonal antibody injection and Humira in patients with moderately to severely active rheumatoid arthritis; the secondary purpose is to evaluate the pharmacokinetic characteristics, safety and immunogenicity of recombinant human anti-TNF-α monoclonal antibody injection and Humira in patients with moderately to severely active rheumatoid arthritis
健康志愿者单次皮下注射重组人源抗TNF-α单克隆抗体注射液的药代动力学比对试验
[Translation] Comparative study on the pharmacokinetic effects of a single subcutaneous injection of recombinant human anti-TNF-α monoclonal antibody in healthy volunteers
主要目的:比较健康志愿者单次皮下注射重组人源抗TNF-α单克隆抗体注射液及其参照药的药代动力学,探讨重组人源抗TNF-α单克隆抗体注射液与参照药是否具有可比拟性。 次要目的:评估健康志愿者单次皮下注射重组人源抗TNF-α单克隆抗体注射液的安全性和免疫原性。
[Translation] Primary objective: To compare the pharmacokinetics of a single subcutaneous injection of recombinant human anti-TNF-α monoclonal antibody injection and its reference drug in healthy volunteers, and to explore whether the recombinant human anti-TNF-α monoclonal antibody injection and the reference drug are comparable. Secondary objective: To evaluate the safety and immunogenicity of a single subcutaneous injection of recombinant human anti-TNF-α monoclonal antibody injection in healthy volunteers.
100 Clinical Results associated with Jiangsu Zhonghe Pharmaceutical Technology Co Ltd
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