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The objective of this study to assess the pharmacokinetics, safety, tolerability and immunogenicity following a single subcutaneous (SC) or intravenous (IV) dose of risankizumab in healthy Chinese participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose A of Risankizumab for Subcutaneous (SC) Injection | Experimental | Participants will receive SC injections of risankizumab at dose A and then followed for 140 days. |
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| Dose B of Risankizumab for Subcutaneous (SC) Injection | Experimental | Participants will receive SC injections of risankizumab at dose B and then followed for 140 days. |
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| Dose C of Risankizumab for Intravenous (IV) Infusion | Experimental | Participants will receive IV infusion of risankizumab at dose C and then followed for 140 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Risankizumab | Drug | Intravenous (IV) Infusion |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events (AE) | An AE is defined as any untoward medical occurrence in a participant 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 |
| Maximum Observed Concentration (Cmax) | Maximum observed concentration. | Up to Approximately 140 Days |
| Time to Cmax (Tmax) | Time to Cmax. | Up to Approximately 140 Days |
| Terminal Phase Elimination Rate Constant (β) | Terminal phase elimination rate constant. | Up to Approximately 140 Days |
| Terminal Phase Elimination Half-life (t1/2) | Terminal phase elimination half-life. | Up to Approximately 140 Days |
| Area Under the Concentration-Time Curve (AUC) from Time 0 to Time of the Last Measurable Concentration (AUCt) | AUC from time 0 to time of the last measurable concentration (AUCt). | Up to Approximately 140 Days |
| AUC from Time 0 to Infinity (AUCinf) | AUC from time 0 to infinity (AUCinf). | Up to Approximately 140 Days |
| Apparent Clearance (CL/F) for Subcutaneous (SC) dosing |
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Inclusion Criteria:
- Body Mass Index (BMI) is >= 19.0 to <= 26.0 kg/m2 after rounding to the nearest tenth. BMI is calculated as weight in kg divided by the square of height measured in meters.
Exclusion Criteria:
- Previous exposure to any anti-IL-12/23 or anti-IL-23 treatment.
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Xuhui Central Hospital /ID# 212830 | Shanghai | Shanghai Municipality | 200031 | China |
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| ID | Term |
|---|---|
| C000601773 | risankizumab |
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| Risankizumab | Drug | Subcutaneous (SC) Injection |
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CL/F for SC dosing. |
| Up to Approximately 140 Days |
| Clearance (CL) for Intravenous (IV) Dosing | CL for IV dosing. | Up to Approximately 140 Days |
| Number of Anti-drug antibody (ADA) Titers | ADA titers will be tabulated for each participant at the respective study visits. | Up to Approximately 140 Days |