Healthy Volunteers
Conditions
Keywords
Healthy Volunteers, Risankizumab, ABBV-066, SKYRIZI
Brief summary
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.
Interventions
DRUGRisankizumab
Intravenous (IV) Infusion
Sponsors
AbbVie
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Adverse Events (AE) | Up to Approximately 140 Days | 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. |
| Maximum Observed Concentration (Cmax) | Up to Approximately 140 Days | Maximum observed concentration. |
| Time to Cmax (Tmax) | Up to Approximately 140 Days | Time to Cmax. |
| Terminal Phase Elimination Rate Constant (β) | Up to Approximately 140 Days | Terminal phase elimination rate constant. |
| Terminal Phase Elimination Half-life (t1/2) | Up to Approximately 140 Days | Terminal phase elimination half-life. |
| Area Under the Concentration-Time Curve (AUC) from Time 0 to Time of the Last Measurable Concentration (AUCt) | Up to Approximately 140 Days | AUC from time 0 to time of the last measurable concentration (AUCt). |
| AUC from Time 0 to Infinity (AUCinf) | Up to Approximately 140 Days | AUC from time 0 to infinity (AUCinf). |
| Apparent Clearance (CL/F) for Subcutaneous (SC) dosing | Up to Approximately 140 Days | CL/F for SC dosing. |
| Clearance (CL) for Intravenous (IV) Dosing | Up to Approximately 140 Days | CL for IV dosing. |
| Number of Anti-drug antibody (ADA) Titers | Up to Approximately 140 Days | ADA titers will be tabulated for each participant at the respective study visits. |
Countries
China
Outcome results
None listed