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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-522345-21-00 | EU Trial (CTIS) Number |
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This is a Phase 1, first-in-human (FIH), randomized, double-blind, single-dose, parallel-group, 3-arm study to compare PK, safety, tolerability, and immunogenicity profiles of CKD-704, EU-approved Skyrizi, and US-licensed Skyrizi in healthy adult participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CKD-704 | Experimental | Singe dose pre-filled syringe, 150mg/ml |
|
| EU-Skyrizi | Active Comparator | Singe dose pre-filled syringe, 150mg/ml |
|
| US-Skyrizi | Active Comparator | Singe dose pre-filled syringe, 150mg/ml |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SKYRIZI | Biological | EU-sourced |
| |
| SKYRIZI |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Serum Concentration (Cmax) | Maximum observed serum concentration (Cmax) of risankizumab. | up to approximately 146 days |
| AUC From Time 0 to Infinity (AUCinf) | AUCinf of risankizumab | Up to approximately 146 days |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under Concentration-Time Curve (AUC) From Time 0 to Time of the Last Measurable Concentration (AUCt) | AUCt of risankizumab | Up to approximately 146 days |
| Terminal Phase Elimination Hhalf-life (t1/2) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anna Dryja, MD | Contact | +48 22 572 59 59 | anna.dryja@pratia.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MTZ powered by Pratia | Recruiting | Warsaw | Warszawa | 02-172 | Poland |
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| Biological |
US-licensed |
|
| CKD-704 | Biological | Risankizumab biosimilar |
|
Terminal phase elimination half-life (t1/2) of risankizumab.
| Up to approximately 146 days |
| Time to Cmax (Tmax) | Time to Cmax of risankizumab | Up to approximately 146 days |
| Safety and tolerability | Incidence and characteristics (severity, etc) of AEs | Up to approximately 146 days |
| 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 |
|---|---|
| C000601773 | risankizumab |
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