[Translation] A single-center, randomized, double-blind, single-dose, parallel-controlled clinical study comparing the pharmacokinetics, pharmacodynamics, safety, and immunogenicity of recombinant anti-RANKL monoclonal antibody injection and denosumab injection (Prolia®) in healthy male subjects
主要研究目的:
评价在健康男性受试者中,单次、皮下注射重组抗RANKL单抗注射液或地舒单抗注射液(Prolia®)后药代动力学的相似性。
次要研究目的:
评价在健康男性受试者中,单次、皮下注射重组抗RANKL单抗注射液或地舒单抗注射液(Prolia®)后安全性和免疫原性的相似性。
初步观察注射重组抗RANKL单抗注射液或地舒单抗注射液(Prolia®)的药效学相似性。
[Translation] Primary study objectives:
To evaluate the similarity of pharmacokinetics after a single, subcutaneous injection of recombinant anti-RANKL monoclonal antibody injection or denosumab injection (Prolia®) in healthy male subjects.
Secondary study objectives:
To evaluate the similarity of safety and immunogenicity after a single, subcutaneous injection of recombinant anti-RANKL monoclonal antibody injection or denosumab injection (Prolia®) in healthy male subjects.
To preliminarily observe the pharmacodynamic similarity of injection of recombinant anti-RANKL monoclonal antibody injection or denosumab injection (Prolia®).