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This study is designed to demonstrate PK similarity of the proposed biosimilar test product CT-P52 and the reference product, US-licensed Taltz.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CT-P52 | Experimental | 80 mg (single dose), subcutaneous (SC) injection via pre-filled syringe (PFS) |
|
| United States (US)-licensed Taltz | Active Comparator | 80 mg (single dose), subcutaneous (SC) injection via pre-filled syringe (PFS) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ixekizumab | Biological | 80 mg (single dose), SC injection via PFS |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-inf | Pharmacokinetic (PK) similarity demonstration in terms of area under the concentration-time curve (AUC) from time zero to infinity (AUC0-inf) | Day 85 |
| Cmax | PK similarity demonstration in terms of maximum serum concentration | Day 85 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inje University Busan Paik Hospital | Busan | Busanjin-gu | South Korea | |||
| CHA Bundang Medical Center |
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| ID | Term |
|---|---|
| C549079 | ixekizumab |
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randomized, double-blind, two-arm, parallel-group, single-dose study designed
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| Seongnam-si |
| Gyeonggi-do |
| South Korea |
| Seoul National University Bundang Hospital | Seongnam-si | Gyeonggi-do | South Korea |
| Chungbuk National University Hospital | Cheongju-si | North Chungcheong | South Korea |
| Seoul National University Hospital | Seoul | South Korea |