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The objective of this study is to evaluate the bioavailability, safety and tolerability of risankizumab following subcutaneous injections in healthy male participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Risankizumab Dose A | Experimental | Participants will receive 3 Subcutaneous (SC) injections of risankizumab Dose A administered via prepared syringe at Day 1 and followed for 140 days. |
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| Risankizumab Dose B | Experimental | Participants will receive 1 SC injection of risankizumab Dose B administered via syringe pump at Day 1 and followed for 140 days. |
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| Risankizumab Dose C | Experimental | Participants will receive 1 SC injection of risankizumab Dose C administered via syringe pump at Day 1 and followed for 140 days. |
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| Risankizumab Dose D | Experimental | Participants will receive 1 SC injection of risankizumab Dose D administered via prepared syringe at Day 1 and followed for 140 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| risankizumab | Drug | Subcutaneous Injection via prepared syringe |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) | Maximum Observed Plasma Concentration | Up to 140 Days |
| Time to maximum observed plasma concentration (Tmax) | Time to maximum observed plasma concentration | Up to 140 Days |
| Area under the plasma concentration-time curve (AUC) from time 0 to the time of last measurable concentration (AUCt) | AUC from time 0 to the time of last measurable concentration | Up to 140 Days |
| AUC from time 0 to infinity (AUCinf) | AUC from time 0 to infinity | Up to 140 Days |
| Terminal phase elimination rate constant (β) | Terminal phase elimination rate constant | Up to 140 Days |
| Terminal phase elimination half-life (t1/2). | Terminal phase elimination half-life | Up to 140 Days |
| Number of Anti-drug antibody (ADA) Titers | Incidence of anti-drug antibodies | Up to 140 Days |
| 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. |
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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# 165737 | Grayslake | Illinois | 60030 | United States |
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| ID | Term |
|---|---|
| C000601773 | risankizumab |
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| risankizumab | Drug | Subcutaneous Injection via syringe pump |
|
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| Up to 140 Days |