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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
32
Peking University People's Hospital
Beijing, Xicheng District, China
RECRUITINGNumber of patients with treatment related adverse events
Number of patients with treatment related adverse events assessed by change from baseline
Time frame: 56 days
Number of patients with abnormal laboratory values
Number of patients with abnormal laboratory values assessed by change from baseline
Time frame: 56 days
Maximum plasma concentration (Cmax)
Time frame: 56 days
Area under the Curve (AUC)
Time frame: 56 days
Number of patients with anti drug antibodies
Time frame: 56 days
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