Healthy Volunteers
Conditions
Brief summary
The objective of this study is to evaluate the bioavailability, safety and tolerability of risankizumab following subcutaneous injections in healthy male participants.
Interventions
DRUGrisankizumab
Subcutaneous Injection via prepared syringe
Sponsors
AbbVie
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Body weight less than 100.00 kg inclusive at Screening and Check-In Day. * Body Mass Index (BMI) is ≥ 18.0 to ≤ 29.9 kg/m2 after rounded to the tenths decimal, at Screening and upon confinement.
Exclusion criteria
* Previous exposure to any anti-IL-12/23 or anti-IL-23 treatment. * History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma), renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Terminal phase elimination rate constant (β) | Up to 140 Days | Terminal phase elimination rate constant |
| Terminal phase elimination half-life (t1/2). | Up to 140 Days | Terminal phase elimination half-life |
| Number of Anti-drug antibody (ADA) Titers | Up to 140 Days | Incidence of anti-drug antibodies |
| Area under the plasma concentration-time curve (AUC) from time 0 to the time of last measurable concentration (AUCt) | Up to 140 Days | AUC from time 0 to the time of last measurable concentration |
| Time to maximum observed plasma concentration (Tmax) | Up to 140 Days | Time to maximum observed plasma concentration |
| AUC from time 0 to infinity (AUCinf) | Up to 140 Days | AUC from time 0 to infinity |
| Maximum Observed Plasma Concentration (Cmax) | Up to 140 Days | Maximum Observed Plasma Concentration |
| 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. |
Countries
United States
Outcome results
None listed