[Translation] A randomized, blinded, single-dose, parallel-controlled, phase I clinical study comparing the pharmacokinetics, safety and immunogenicity of KN012 and Prolia in healthy subjects
主要研究目的 观察重组全人源抗RANKL单克隆抗体注射液的药代动力学特征,并以Denosumab(商品名:Prolia )为参比制剂,比较两制剂的主要药代动力学参数,评价两制剂的药代动力学相似性。 次要研究目的 比较受试制剂重组全人源抗RANKL单克隆抗体注射液和参比制剂Prolia 在健康受试者中单次给予60 mg的安全性以及临床免疫原性。
[Translation] Main research objective To observe the pharmacokinetic characteristics of recombinant fully human anti-RANKL monoclonal antibody injection, and to compare the main pharmacokinetic parameters of the two preparations with Denosumab (trade name: Prolia) as the reference preparation, and to evaluate the two preparations pharmacokinetic similarity. Secondary research objectives To compare the safety and clinical immunogenicity of the test preparation recombinant fully human anti-RANKL monoclonal antibody injection and the reference preparation Prolia at a single dose of 60 mg in healthy subjects.