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This study will assess the pharmacokinetics, relative bioavailability and tolerability of two formulations of risankizumab following subcutaneous (SC) administration in healthy adult participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Risankizumab Formulation 1 | Experimental | Participants will receive a single dose of Risankizumab formulation 1 on day 1. |
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| Risankizumab Formulation 2 | Experimental | Participants will receive a single dose of Risankizumab formulation 2 on day 1. |
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| Risankizumab Formulation 3 | Experimental | Participants will receive a single dose of Risankizumab formulation 3 on day 1. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Risankizumab | Drug | • Subcutaneous Injection via prefilled syringe |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events (AEs) | An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. | Up to day 140 |
| Maximum Observed Serum Concentration (Cmax) of Risankizumab | Cmax will be assessed of Risankizumab | Up to Day 140 |
| Time to Cmax (Tmax) of Risankizumab | Tmax will be assessed of Risankizumab | Up to Day 140 |
| Apparent Terminal Phase Elimination Rate Constant (β) of Risankizumab | Apparent terminal phase elimination rate constant (β) will be assessed of Risankizumab | Up to Day 140 |
| Terminal Phase Elimination Half-life (t1/2) of Risankizumab | Terminal phase elimination half-life (t1/2) will be assessed of Risankizumab | Up to Day 140 |
| Area Under the Concentration-time Curve (AUC) from Time 0 to Time of the Last Measurable Concentration (AUC0-t) | AUC0-t will be assessed | Up to Day 140 |
| AUC from Time 0 to Infinity (AUC0-inf) of Risankizumab | AUC0-inf will be assessed of Risankizumab | Up to Day 140 |
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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 |
|---|---|---|---|---|---|---|
| Cenexel Act /ID# 270310 | Anaheim | California | 92801 | United States | ||
| Collaborative Neuroscience Research CNS /ID# 270286 |
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|
| Number of Anti-drug antibody (ADA) Titers | Incidence and concentration of anti-drug antibodies | Up to Day 140 |
| Los Alamitos |
| California |
| 90720 |
| United States |
| Acpru /Id# 270152 | Grayslake | Illinois | 60030 | United States |
| ID | Term |
|---|---|
| C000601773 | risankizumab |
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