A randomized, double-blind and parallel group study to compare the pharmacokinetic, safety and pharmacodynamic of MW032 and Xgeva® in healthy adults.
This is a phase I, single center, randomized, double-blind and parallel group clinical trial. The primary objective is to assess the pharmacokinetic similarity of single and subcutaneous injections of MW032 and Xgeva® in healthy volunteers. The secondary objective are to assess the Clinical safety and immunogenicity similarity of single and subcutaneous injections of MW032 and Xgeva® in healthy volunteers. At the same time, preliminary evaluate the pharmacodynamic similarity between MW032 and Xgeva®. Subjects would receive a single 120mg(1.7mL)of MW032 or Xgeva® through subcutaneous injection.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
120
PKUCare Luzhong Hospital
Zibo, Shandong, China
Area under the plasma concentration-time curve (AUC0-t )
Time frame: Day0-Day161
Maximum serum concentration (Cmax)
Time frame: Day0-Day161
Adverse events(AE)
The adverse medical events that occur after the clinical trial subjects receive the test drug do not necessarily have a causal relationship with the treatment.
Time frame: Day0-Day161
serum CTX1
CTX1 is a serum type I collagen C-terminal peptide to detect the bone metastasis events.
Time frame: Day0-Day161
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