This study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of denosumab administered subcutaneously to healthy adults in China.
Denosumab is a fully human monoclonal IgG2 antibody to RANKL that being investigated as a therapeutic agent in all bone diseases characterized by excessive bone resorption, such as primary and secondary osteoporosis, metastatic bone diseases, and other diseases involving bone loss associated with increases in osteoclast function. This will be a single-blind, placebo-controlled single-dose study. All subjects will be randomized to denosuamb 60 mg, denosumab 120 mg or placebo in a ration of 3:3:2. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of denosumab administered subcutaneously to healthy adults in China. The primary endpoints for safety are: subject incidence of treatment-emergent adverse events, including clinically significant changes in physical examinations, laboratory safety tests, ECG and vital signs. The secondary endpoints are PK and PD (s-CTX1) parameter estimates.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
64
GSK Investigational Site
Shanghai, China
adverse events
subjects incidence of treatment adverse events, including clinically-significant changes in physical examinations, laboratory safety tests, ECG and vital signs
Time frame: up to 26 weeks
PK parameter estimates
Cmax, Tmax, AUC(0-t),
Time frame: up to 19 weeks
PD parameter estimateds
serum CTX1
Time frame: up to 19 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.