Healthy Volunteers
Conditions
Keywords
Healthy Volunteers, Risankizumab, Skyrizi
Brief summary
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.
Interventions
DRUGRisankizumab
Intravenous (IV) Infusion
DRUGPlacebo
Intravenous (IV) Infusion
Sponsors
AbbVie
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Must be first or second generation Japanese of full parentage residing outside of Japan for less than 10 years. First generation participants will have been born to two parents and four grandparents also born in Japan of full Japanese descent. Second generation participants born outside of Japan must have two parents and four grandparents born in Japan of full Japanese descent. All participants must maintain a typical Japanese lifestyle, including consuming a typical Japanese diet or participants must be Caucasian and not of Hispanic ethnicity. * Body Mass Index (BMI) is \>= 18.5 and \<= 29.9 kg/m2 (after rounding to the tenths decimal) at Screening. BMI is calculated as weight in kilograms (kg) divided by the square of height measured in meters (m).
Exclusion criteria
* Previous exposure to any anti-IL-12/23 or anti-IL-23 treatment. * Any findings in the medical examination that are deviating from normal and judged as clinically relevant by the investigator. * Any laboratory value outside the reference range that the investigator considers to be of clinical relevance. * Any evidence of a concomitant disease judged as clinically relevant by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Experiencing Adverse Events | Up to approximately 137 days | 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. |
| Maximum Observed Plasma Concentration (Cmax) of Risankizumab | Up to approximately 137 days | Maximum observed plasma concentration (Cmax) of Risankizumab. |
| Time to Cmax (Cmax) of Risankizumab | Up to approximately 137 days | Tmax of Risankizumab. |
| Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to the Last Measurable Concentration (AUCt) of Risankizumab | Up to approximately 137 days | AUCt of Risankizumab. |
| Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Infinity (AUCinf) of Risankizumab | Up to approximately 137 days | AUCinf of Risankizumab. |
| Apparent Terminal Phase Elimination Rate Constant (β) of Risankizumab | Up to approximately 137 days | Apparent terminal phase elimination rate constant (β) of Risankizumab. |
| Terminal Phase Elimination Half-life (t1/2) of Risankizumab | Up to approximately 137 days | Terminal phase elimination half-life (t1/2) of Risankizumab. |
Countries
United States
Outcome results
None listed