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The objective of this study is to compare pharmacokinetic exposures following intravenous and subcutaneous administration of Risankizumab.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Risankizumab Dose A for Intravenous (IV) Infusion | Experimental | Participants will receive IV infusion of risankizumab at dose A and then followed for 140 days. |
|
| Risankizumab Dose B for Subcutaneous (SC) Injection | Experimental | Participants will receive SC injections of risankizumab at dose B and then followed for 140 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Risankizumab | Drug | Intravenous (IV) Infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Experiencing Adverse Events | An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. | Up to approximately 140 days |
| Maximum Observed Serum Concentration (Cmax) of Risankizumab | Cmax of Risankizumab. | Up to approximately 140 days |
| Time to Cmax (Tmax) of Risankizumab | Tmax of Risankizumab. | Up to approximately 140 days |
| Area Under the Serum Concentration-Time Curve (AUC) of Risankizumab | AUCt of Risankizumab. | Up to approximately Week 4 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Pharmacology Of Miami /ID# 268219 | Miami | Florida | 33014 | United States | ||
| Acpru /Id# 267057 |
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| ID | Term |
|---|---|
| C000601773 | risankizumab |
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| Risankizumab | Drug | Subcutaneous (SC) Injection |
|
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| Grayslake |
| Illinois |
| 60030 |
| United States |