Healthy Volunteers
Conditions
Keywords
Healthy Volunteers, Risankizumab
Brief summary
This study will assess the pharmacokinetics, relative bioavailability, immunogenicity, safety, and tolerability of risankizumab following subcutaneous (SC) administration with a prefilled pen or a prefilled syringe in healthy adult participants.
Interventions
DRUGRisankizumab
Subcutaneous 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) ≥ 18.0 to ≤ 32.0 kg/m\^2 after rounding to the tenths decimal at the time of screening and upon initial confinement. BMI is calculated as weight in kg divided by the square of height measured in meters. * Body weight greater than 40 kg and less than 100 kg at screening and upon initial confinement. * 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-12/23 or anti interleukin-23 treatment for at least one year prior to Screening. * Intention to perform strenuous exercise to which the participant is unaccustomed within one week prior to administration of first dose of study drug and during the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of Risankizumab | Up to approximately 141 days | Maximum observed plasma concentration (Cmax) of Risankizumab |
| Time to Cmax (Tmax) of Risankizumab | Up to approximately 141 days | Tmax of Risankizumab |
| Apparent Terminal Phase Elimination Rate Constant (β) of Risankizumab | Up to approximately 141 days | Apparent terminal phase elimination rate constant (β) of Risankizumab |
| Terminal Phase Elimination Half-life (t1/2) of Risankizumab | Up to approximately 141 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 141 days | AUCt of Risankizumab |
| Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Infinity (AUCinf) of Risankizumab | Up to approximately 141 days | AUCinf of Risankizumab |
| Number of Participants Experiencing Adverse Events | Up to approximately 141 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
Outcome results
None listed