[Translation] A single-center, randomized, double-blind, single-dose, parallel-controlled pharmacokinetics and pharmacodynamics of recombinant anti-RANKL monoclonal antibody injection and denosumab injection (Prolia®) in healthy male subjects , clinical studies comparing safety and immunogenicity
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] Main research purposes:
To evaluate the similarity in pharmacokinetics following a single, subcutaneous injection of recombinant anti-RANKL monoclonal antibody injection or denosumab injection (Prolia®) in healthy male subjects.
Secondary research purpose:
To evaluate the similarity in safety and immunogenicity following a single, subcutaneous injection of recombinant anti-RANKL monoclonal antibody injection or denosumab injection (Prolia®) in healthy male subjects.
Preliminary observation of the pharmacodynamic similarities between injecting recombinant anti-RANKL monoclonal antibody injection or denosumab injection (Prolia®).