This is a randomized, double-blinded, controlled Phase I three-arms study of CMAB807X administered by subcutaneous injection. This study will characterize the pharmacokinetic, pharmacodynamics, safety and immunogenicity of CMAB807X Pre- and Post-change in Manufacturing Site, and Post-change CMAB807X versus Xgeva® #Denosumab# in healthy male subjects after a single dose
This is a randomized, double-blind, parallel-controlled, single-dose phase I three-arms clinical study in healthy Chinese male subjects. A total of 252 subjects were planned to be enrolled and randomly assigned to the test group or the bridging control group or bioequivalence control group in a 1:1:1 ratio. Subjects in three groups received a single abdominal subcutaneous injection of pre- or post-change CMAB807X or Xgeva® #Denosumab# 120 mg, respectively. Subjects in three groups were observed for 140 days after administration to evaluate similarities in pharmacokinetics, pharmacodynamics, safety, and immunogenicity.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
for subcutaneous injection only
for subcutaneous injection only
for subcutaneous injection only
The Second Hospital of Anhui Medical University
Hefei, Anhui, China
Area Under the Plasma Concentration-time Curve From Zero (0) Hours Extrapolated to infinite time
Area Under the Plasma Concentration-time Curve From Zero (0) Hours Extrapolated to infinite time After the Single injection of Denosumab
Time frame: up to 3336 hours
Maximum Concentration of Denosumab
Maximum Concentration of Denosumab After the Single Injection of denosumab
Time frame: up to 3336 hours
Time to Maximum Concentration of Denosumab
Time to Maximum Concentration of Denosumab after the Single Injection of
Time frame: up to 3336 hours
Area Under the Plasma Concentration-time Curve From Zero (0) Hours to 3336 Hours
Area Under the Plasma Concentration-time Curve From Zero (0) Hours to 3336 Hours After the Single Injection of Denosumab
Time frame: up to 3336 hours
Half time
Half-time after the Single Injection of Denosumab
Time frame: up to 3336 hours
Clearance Rate
Clearance Rate after the Single Injection of Denosumab
Time frame: up to 3336 hours
Apparent Volume of Distribution
Apparent Volume of Distribution after the Single Injection of Denosumab
Time frame: up to 3336 hours
Serum type 1 C-telopeptide (CTX1)
CTX1 level in the serum samples from subjects
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: up to 3336 hours
anti-drug antibodies(ADA)
ADA Positive Rate after the Single Injection of Denosumab
Time frame: up to 3336 hours
Neutralization antibodies(Nab)
Neutralizing Antibody Positive Rate after the Single Injection of Denosumab
Time frame: up to 3336 hours