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This study will assess the pharmacokinetics and relative Bioavailability of risankizumab following subcutaneous (SC) administration with on-body Injector in Healthy Adult Participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Risankizumab Arm A | Experimental | Participants will receive a single dose of Risankizumab On-Body Injector (OBI) produced by new process on Day 1. |
|
| Risankizumab Arm B | Experimental | Participants will receive a single dose of Risankizumab On-Body Injector (OBI) produced by current process on Day 1. |
|
| 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 140 days |
| Time to Cmax (Tmax) of Risankizumab | Tmax of Risankizumab | Up to approximately 140 days |
| Apparent Terminal Phase Elimination Rate Constant (β) of Risankizumab | Apparent terminal phase elimination rate constant (β) of Risankizumab | Up to approximately 140 days |
| Terminal Phase Elimination Half-life (t1/2) of Risankizumab | Terminal phase elimination half-life (t1/2) of Risankizumab | Up to approximately 140 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 140 days |
| Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Infinity (AUCinf) of Risankizumab | AUCinf of Risankizumab | Up to approximately 140 days |
| Number of Anti-drug antibody (ADA) Titers | Incidence and concentration of anti-drug antibodies | Up to approximately 140 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 |
|---|---|---|---|---|---|---|
| CenExel ACT- Anaheim Clinical Trials /ID# 274805 | Anaheim | California | 92801 | United States | ||
| Collaborative Neuroscience Research CNS /ID# 275212 |
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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 140 days |
| Los Alamitos |
| California |
| 90720 |
| United States |
| Cpmi /Id# 274464 | Miami | Florida | 33172 | United States |
| Acpru /Id# 271954 | Grayslake | Illinois | 60030 | United States |
| ID | Term |
|---|---|
| C000601773 | risankizumab |
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