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This study will assess the pharmacokinetics and relative Bioavailability of risankizumab following subcutaneous administration with an on-body injector relative to a prefilled syringe
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Risankizumab Prefilled Syringe (PFS) | Experimental | Participants will receive a Subcutaneous (SC) single dose of Risankizumab PFS on Day 1 |
|
| Arm 2: Risankizumab On-Body Injector (OBI) | Experimental | Participants will receive a Subcutaneous (SC) single dose of Risankizumab OBI on Day 1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Risankizumab | Drug | Subcutaneous (SC) Injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of Risankizumab | Maximum observed plasma concentration (Cmax) of Risankizumab | Up to Approximately 113 days |
| Time to Cmax (Tmax) of Risankizumab | Tmax of Risankizumab | Up to Approximately 113 days |
| Apparent Terminal Phase Elimination Rate Constant (β) of Risankizumab | Apparent terminal phase elimination rate constant (β) of Risankizumab | Up to Approximately 113 days |
| Terminal Phase Elimination Half-life (t1/2) of Risankizumab | Terminal phase elimination half-life (t1/2) of Risankizumab | Up to Approximately 113 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 113 days |
| Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Infinity (AUCinf) of Risankizumab | AUCinf of Risankizumab | Up to Approximately 113 days |
| Number of Anti-drug antibodies (ADA) | Incidence of anti-drug antibodies | Up to Approximately 113 days |
| Number of Participants Experiencing Adverse Events |
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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 |
|---|---|---|---|---|---|---|
| Cpmi /Id# 276490 | Miami | Florida | 33172 | United States | ||
| Acpru /Id# 276043 |
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| Risankizumab |
| Drug |
On-Body Injector (OBI) |
|
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 113 days |
| Grayslake |
| Illinois |
| 60030 |
| United States |
| Ppd - Las Vegas Research Unit /ID# 276565 | Las Vegas | Nevada | 89113 | United States |
| PPD Phase I Clinic /ID# 276525 | Austin | Texas | 78744 | United States |
| ID | Term |
|---|---|
| C000601773 | risankizumab |
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