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It is a randomized, double-blinded, single-dose, 3-arm parallel, comparative study to evaluate the pharmacokinetics, safety and immunogenicity of BAT2306 Injection vs Cosentyx® (EU-licensed and US-licensed) in healthy Chinese male subjects. A total of 216 healthy male subjects are planned to be included and randomized at a ratio of 1:1:1 to receive single 150mg BAT2306 Injection or Cosentyx® (EU-licensed and US-licensed).
The study has a screening period of 14 days. PK blood samples will be collected from subjects to determine the serum concentration of Secukinumab, thus to evaluate the similarity of the pharmacokinetics of the three study drugs.
The investigator will perform safety evaluation for vital signs, physical examinations, injection site reaction, ECG, clinical laboratory tests and adverse events throughout the study. Immunogenicity evaluation (ADA, ADA titration and NAb) will also be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BAT2306 injection | Experimental | 150mg /1ml; subcutaneous injection |
|
| Cosentyx (US-licensed) | Active Comparator | 150mg /1ml; subcutaneous injection |
|
| Cosentyx (EU-licensed) | Active Comparator | 150mg /1ml; subcutaneous injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BAT2306 | Drug | 150mg/1 ml; single dose;prefilled syringe; subcutaneous injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics Endpoint:Peak plasma concentration (Cmax) | Pharmacokinetics Endpoint:Peak plasma concentration (Cmax) | 0-5months |
| Pharmacokinetics Endpoint:Area under the plasma concentration versus time curve (AUC0-inf) | Pharmacokinetics Endpoint:Area under the plasma concentration versus time | 0-5months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yanhua Ding | The First Hospital of Jinlin University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Hospital of Jilin University | Changchun | Jilin | China |
Only one site study
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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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| Cosentyx (US-licensed) |
| Drug |
150mg/1 ml; single dose;prefilled syringe; subcutaneous injection |
|
|
| Cosentyx (EU-licensed) | Drug | 150mg/1 ml; single dose;prefilled syringe; subcutaneous injection |
|
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