This is a randomized, double-blinded, controlled Phase I study of new process CMAB015 administered by subcutaneous injection. This study will characterize the pharmacokinetic, safety and immunogenicity of new process CMAB015 versus Cosentyx(Secukinumab ) 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 114 subjects were planned to be enrolled and randomly assigned to the test group or the control group in a 1:1 ratio. Subjects in both groups received a single upper arm subcutaneous injection of new process CMAB015 or Cosentyx(Secukinumab) 150 mg, respectively. Subjects in both groups were observed for 112 days after administration to evaluate similarities in pharmacokinetics, safety, and immunogenicity.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
114
for subcutaneous injection only
Shanghai Jiaotong University School of Medicine
Shanghai, 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 new process CMAB015/Cosentyx
Time frame: up to 2688 hours
Maximum Concentration of Secukinumab
Maximum Concentration of Secukinumab After the Single Injection of new process CMAB015/Cosentyx
Time frame: up to 2688 hours
Time to Maximum Concentration of Secukinumab
Time to Maximum Concentration of Secukinumab after the Single Injection of new process CMAB015/Cosentyx
Time frame: up to 2688 hours
Area Under the Plasma Concentration-time Curve From Zero (0) Hours to 2688 Hours
Area Under the Plasma Concentration-time Curve From Zero (0) Hours to 2688 Hours After the Single Injection of new process CMAB015/Cosentyx
Time frame: up to 2688 hours
Half time
Half-time after the Single Injection of new process CMAB015/Cosentyx
Time frame: up to 2688 hours
Terminal phase elimination rate constant
Terminal phase elimination rate constant after the Single Injection of new process CMAB015/Cosentyx
Time frame: up to 2688 hours
Clearance Clearance
Clearance Rate after the Single Injection of new process CMAB015/Cosentyx
Time frame: up to 2688 hours
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Apparent Volume of Distribution
Terminal phase elimination rate constant after the Single Injection of new process CMAB015/Cosentyx
Time frame: up to 2688 hours
anti-drug antibodies(ADA)
ADA Positive Rate after the Single Injection of new process CMAB015/Cosentyx
Time frame: up to 2688 hours
Neutralization antibodies(Nab)
Neutralizing Antibody Positive Rate after the Single Injection of new process CMAB015/Cosentyx
Time frame: up to 2688 hours
Percentage of participants with Adverse Events
Total Frequency of Adverse Events/Serious Adverse Events Within the Whole Time of the Study
Time frame: up to 2688 hours