This is a randomized, double-blinded, parallel-controlled Phase I study of CMAB807 administered by subcutaneous injection. This study will characterize the pharmacokinetic, pharmacodynamics, safety and immunogenicity of CMAB807 Post-change in Manufacturing Site, versus Prolia #Denosumab# in healthy male subjects after a single dose
This is a randomized, double-blind, parallel-controlled, single-dose phase I clinical study in healthy Chinese male subjects. A total of 132 subjects were planned to be enrolled and randomly assigned to the test group or bioequivalence control group in a 1:1 ratio. Subjects in two groups received a single abdominal subcutaneous injection of post-change CMAB807 or Prolia #Denosumab# 60 mg, respectively. Subjects in three groups were observed for 126 days after administration to evaluate similarities in pharmacokinetics, pharmacodynamics, safety, and immunogenicity.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
128
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 3000 hours
Maximum Concentration of Denosumab
Maximum Concentration of Denosumab After the Single Injection of denosumab
Time frame: up to 3000 hours
Time to Maximum Concentration of Denosumab
Time to Maximum Concentration of Denosumab after the Single Injection of Denosumab
Time frame: up to 3000 hours
Area Under the Plasma Concentration-time Curve From Zero (0) Hours to 3000 Hours
Area Under the Plasma Concentration-time Curve From Zero (0) Hours to 3000 Hours After the Single Injection of Denosumab
Time frame: up to 3000 hours
Half-time
Half-time after the Single Injection of Denosumab
Time frame: up to 3000 hours
Clearance Rate
Clearance Rate after the Single Injection of Denosumab
Time frame: up to 3000 hours
Apparent Volume
Apparent Volume of Distribution after the Single Injection of Denosumab
Time frame: up to 3000 hours
Serum type 1 C-telopeptide (CTX1)
CTX1 level in the serum samples from subjects
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Time frame: up to 3000 hours
anti-drug antibodies(ADA)
ADA Positive Rate after the Single Injection of Denosumab
Time frame: up to 3000 hours
Neutralization antibodies(Nab)
Neutralizing Antibody Positive Rate after the Single Injection of Denosumab
Time frame: up to 3000 hours