Healthy Volunteers
Conditions
Brief summary
The objective of this study is to evaluate the bioavailability of risankizumab new formulation in prefilled syringe (PFS) relative to the 90 mg/mL formulation in PFS in healthy volunteers. The study will also evaluate the bioavailability of risankizumab new formulation in auto-injector (AI) relative to PFS in healthy volunteers.
Interventions
DRUGRisankizumab
Subcutaneous Injection via Prefilled Syringe (PFS)
Sponsors
AbbVie
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Male and female healthy volunteers between 18 and 55 years of age. * Body weight less than 110.00 kg inclusive at Screening.
Exclusion criteria
* Previous exposure to any anti-IL-12/23 or anti-IL-23 treatment. * Intention to perform strenuous exercise to which the subject is unaccustomed within one week prior to administration of study drug or during the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Adverse Events | Up to 140 Days | An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with the treatment. The investigator assesses the relationship of each event to the use of study drug. |
| Maximum observed serum concentration (Cmax) | Up to 113 Days | Maximum observed serum concentration |
| Time to Cmax (Tmax) | Up to 113 Days | Time to Cmax |
| Terminal phase elimination rate constant (β) | Up to 113 Days | Terminal phase elimination rate constant |
| Terminal phase elimination half-life (t1/2) | Up to 113 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 113 Days | AUC from 0 to time of last measurable concentration |
| AUC from time 0 to infinity (AUCinf) | Up to 113 Days | AUC from time 0 to infinity |
| Number of Anti-drug antibody (ADA) Titers | Up to 113 Days | Incidence of anti-drug antibodies |
Countries
United States
Outcome results
None listed