Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The main objective of this study is to assess the pharmacokinetics, safety, tolerability and immunogenicity following a single intravenous (IV) infusion of risankizumab in healthy Japanese and Caucasian participants.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Japanese Participants Receiving Risankizumab | Experimental | Participants will receive single dose of risankizumab. |
|
| Japanese Participants Receiving Placebo | Experimental | Participants will receive single dose of placebo. |
|
| Caucasian Participants Receiving Risankizumab | Experimental | Participants will receive single dose of risankizumab. |
|
| Caucasian Participants Receiving Placebo | Experimental | Participants will receive single dose of placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Risankizumab | Drug | Intravenous (IV) Infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Experiencing Adverse Events | 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 137 days |
| Maximum Observed Plasma Concentration (Cmax) of Risankizumab | Maximum observed plasma concentration (Cmax) of Risankizumab. | Up to approximately 137 days |
| Time to Cmax (Cmax) of Risankizumab | Tmax of Risankizumab. | Up to approximately 137 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 137 days |
| Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Infinity (AUCinf) of Risankizumab | AUCinf of Risankizumab. | Up to approximately 137 days |
| Apparent Terminal Phase Elimination Rate Constant (β) of Risankizumab | Apparent terminal phase elimination rate constant (β) of Risankizumab. | Up to approximately 137 days |
| Terminal Phase Elimination Half-life (t1/2) of Risankizumab | Terminal phase elimination half-life (t1/2) of Risankizumab. |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Altasciences Clinical Los Angeles, Inc /ID# 164197 | Cypress | California | 90630 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C000601773 | risankizumab |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Intravenous (IV) Infusion |
|
| Up to approximately 137 days |