Healthy Volunteers
Conditions
Brief summary
This study will assess the pharmacokinetics and relative Bioavailability of risankizumab following subcutaneous administration with an on-body injector relative to a prefilled syringe
Interventions
DRUGRisankizumab
Subcutaneous (SC) Injection
Sponsors
AbbVie
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Body Mass Index (BMI) is ≥ 18.0 to ≤ 32 kg/m2 after rounding to the tenths decimal at screening. BMI is calculated as weight in kg divided by the square of height measured in meters. * Body weight between 40 kg and 100 kg, inclusive, at the time of screening. * A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead ECG.
Exclusion criteria
* Previous exposure to any anti-interleukin (IL)-12/23 or anti IL-23 treatment for at least one year prior to screening. * Intention to perform strenuous exercise within one week prior to administration of study treatment and during the study confinement.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of Risankizumab | Up to Approximately 113 days | Maximum observed plasma concentration (Cmax) of Risankizumab |
| Time to Cmax (Tmax) of Risankizumab | Up to Approximately 113 days | Tmax of Risankizumab |
| Apparent Terminal Phase Elimination Rate Constant (β) of Risankizumab | Up to Approximately 113 days | Apparent terminal phase elimination rate constant (β) of Risankizumab |
| Terminal Phase Elimination Half-life (t1/2) of Risankizumab | Up to Approximately 113 days | Terminal phase elimination half-life (t1/2) of Risankizumab |
| Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to the Last Measurable Concentration (AUCt) of Risankizumab | Up to Approximately 113 days | AUCt of Risankizumab |
| Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Infinity (AUCinf) of Risankizumab | Up to Approximately 113 days | AUCinf of Risankizumab |
| Number of Anti-drug antibodies (ADA) | Up to Approximately 113 days | Incidence of anti-drug antibodies |
| Number of Participants Experiencing Adverse Events | Up to Approximately 113 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 |
Countries
United States
Contacts
STUDY_DIRECTORABBVIE INC.
AbbVie
Outcome results
None listed