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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biosimilar Product | Experimental | new process CMAB015(Secukinumab ) 150 mg Subcutaneous injection in upper arm |
|
| Reference Product | Active Comparator | Cosentyx(Secukinumab ) 150 mg Subcutaneous injection in upper arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Secukinumab 150mg s.c. | Biological | for subcutaneous injection only |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | up to 2688 hours |
| Maximum Concentration of Secukinumab | Maximum Concentration of Secukinumab After the Single Injection of new process CMAB015/Cosentyx | up to 2688 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Maximum Concentration of Secukinumab | Time to Maximum Concentration of Secukinumab after the Single Injection of new process CMAB015/Cosentyx | up to 2688 hours |
| Area Under the Plasma Concentration-time Curve From Zero (0) Hours to 2688 Hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Jiaotong University School of Medicine | Shanghai | China |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C555450 | secukinumab |
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Biological: new process CMAB015(Secukinumab ) Biological: Cosentyx(Secukinumab )
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Area Under the Plasma Concentration-time Curve From Zero (0) Hours to 2688 Hours After the Single Injection of new process CMAB015/Cosentyx
| up to 2688 hours |
| Half time | Half-time after the Single Injection of new process CMAB015/Cosentyx | up to 2688 hours |
| Terminal phase elimination rate constant | Terminal phase elimination rate constant after the Single Injection of new process CMAB015/Cosentyx | up to 2688 hours |
| Clearance Clearance | Clearance Rate after the Single Injection of new process CMAB015/Cosentyx | up to 2688 hours |
| Apparent Volume of Distribution | Terminal phase elimination rate constant after the Single Injection of new process CMAB015/Cosentyx | up to 2688 hours |
| anti-drug antibodies(ADA) | ADA Positive Rate after the Single Injection of new process CMAB015/Cosentyx | up to 2688 hours |
| Neutralization antibodies(Nab) | Neutralizing Antibody Positive Rate after the Single Injection of new process CMAB015/Cosentyx | 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 | up to 2688 hours |