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This study will assess the pharmacokinetics, relative bioavailability, immunogenicity, safety, and tolerability of risankizumab following subcutaneous (SC) administration with a prefilled pen or a prefilled syringe in healthy adult participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Risankizumab Arm A | Experimental | Participants will receive a single Subcutaneous (SC) injection of risankizumab Dose A administered via Prefilled Syringe (PFS) at Day 1 |
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| Risankizumab Arm B | Experimental | Participants will receive a single Subcutaneous (SC) injection of risankizumab Dose B administered via Prefilled Pen (PFP) at Day 1 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Risankizumab | Drug | Subcutaneous Injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of Risankizumab | Maximum observed plasma concentration (Cmax) of Risankizumab | Up to approximately 141 days |
| Time to Cmax (Tmax) of Risankizumab | Tmax of Risankizumab | Up to approximately 141 days |
| Apparent Terminal Phase Elimination Rate Constant (β) of Risankizumab | Apparent terminal phase elimination rate constant (β) of Risankizumab | Up to approximately 141 days |
| Terminal Phase Elimination Half-life (t1/2) of Risankizumab | Terminal phase elimination half-life (t1/2) of Risankizumab | Up to approximately 141 days |
| Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to the Last Measurable Concentration (AUCt) of Risankizumab | AUCt of Risankizumab | Up to approximately 141 days |
| Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Infinity (AUCinf) of Risankizumab | AUCinf of Risankizumab | Up to approximately 141 days |
| 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 |
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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 |
|---|---|---|---|---|---|---|
| Altasciences Clinical Los Angeles /ID# 276446 | Cypress | California | 90630 | United States | ||
| Acpru /Id# 275116 |
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| Up to approximately 141 days |
| Grayslake |
| Illinois |
| 60030 |
| United States |
| ID | Term |
|---|---|
| C000601773 | risankizumab |
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