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The objective of this study is to evaluate the bioavailability of risankizumab new formulation in prefilled syringe (PFS) relative to the 90 mg/mL formulation in PFS in healthy volunteers. The study will also evaluate the bioavailability of risankizumab new formulation in auto-injector (AI) relative to PFS in healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Risankizumab Dose A | Experimental | Participants will receive 1 Subcutaneous (SC) injection of risankizumab Dose A administered via Prefilled Syringe (PFS) at Day 1 and followed for 140 days |
|
| Risankizumab Dose B | Experimental | Participants will receive SC injections of risankizumab Dose B administered via PFS at Day 1 and followed for 140 days |
|
| Risankizumab Dose C | Experimental | Participants will receive 1 SC injection of risankizumab Dose C administered via Auto-Injector (AI) at Day 1 and followed for 140 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Risankizumab | Drug | Subcutaneous Injection via Prefilled Syringe (PFS) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events | An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with the treatment. The investigator assesses the relationship of each event to the use of study drug. | Up to 140 Days |
| Maximum observed serum concentration (Cmax) | Maximum observed serum concentration | Up to 113 Days |
| Time to Cmax (Tmax) | Time to Cmax | Up to 113 Days |
| Terminal phase elimination rate constant (β) | Terminal phase elimination rate constant | Up to 113 Days |
| Terminal phase elimination half-life (t1/2) | Terminal phase elimination half-life | Up to 113 Days |
| Area under the concentration-time curve (AUC) from time 0 to time of the last measurable concentration (AUCt) | AUC from 0 to time of last measurable concentration | Up to 113 Days |
| AUC from time 0 to infinity (AUCinf) | AUC from time 0 to infinity | Up to 113 Days |
| Number of Anti-drug antibody (ADA) Titers |
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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 |
|---|---|---|---|---|---|---|
| Acpru /Id# 210844 | Grayslake | Illinois | 60030 | United States | ||
| PPD Clinical Research Unit - Austin /ID# 211456 |
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| ID | Term |
|---|---|
| C000601773 | risankizumab |
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| Risankizumab | Drug | Subcutaneous Injection via Auto-Injector (AI) |
|
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Incidence of anti-drug antibodies |
| Up to 113 Days |
| Austin |
| Texas |
| 78744 |
| United States |