This is a randomized, double-blind, parallel-group, placebo-controlled, single-dose escalation Phase I study in healthy adults in China, conducted in one center.~The objectives are to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of denosumab injection (code name:LY06006).~Subjects would be sequentially enrolled in one of three cohorts. Eight subjects in the first cohort would receive a single 18 mg subcutaneous injection of LY06006. If the safety and tolerability were confirmed at Day 56, the other 16 subjects would be enrolled in the second cohort to receive a single 60 mg subcutaneous injection of LY06006. If the safety and tolerability were confirmed at Day 56 in 60-mg group, the last 8 subjects would be enrolled in the third cohort to receive a single 120 mg subcutaneous injection of LY06006.
This is a randomized, double-blind, parallel-group, placebo-controlled, single-dose escalation Phase I study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of denosumab injection administered subcutaneously to healthy adults in China