Healthy Volunteers
Conditions
Keywords
Healthy Volunteers, Risankizumab, ABBV-066
Brief summary
This study will assess the pharmacokinetics, relative bioavailability and tolerability of two formulations of risankizumab following subcutaneous (SC) administration in healthy adult participants.
Interventions
DRUGRisankizumab
• Subcutaneous Injection via prefilled syringe
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 weight 40 kg to 100 kg, inclusive, at screening and upon initial confinement * Body Mass Index (BMI) is \> = 18.0 to \< = 32.0 kg/m2 after rounded to the tenths decimal, at Screening and upon 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
* Participant with exposure to any anti-interleukin-12/23 or anti-interleukin-23 treatment for at least one year prior to Screening. * Participant with intention to perform strenuous exercise within at least one week prior to administration of study drug or during the study. * History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Adverse Events (AEs) | Up to day 140 | An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. |
| Maximum Observed Serum Concentration (Cmax) of Risankizumab | Up to Day 140 | Cmax will be assessed of Risankizumab |
| Time to Cmax (Tmax) of Risankizumab | Up to Day 140 | Tmax will be assessed of Risankizumab |
| Apparent Terminal Phase Elimination Rate Constant (β) of Risankizumab | Up to Day 140 | Apparent terminal phase elimination rate constant (β) will be assessed of Risankizumab |
| Terminal Phase Elimination Half-life (t1/2) of Risankizumab | Up to Day 140 | Terminal phase elimination half-life (t1/2) will be assessed of Risankizumab |
| Area Under the Concentration-time Curve (AUC) from Time 0 to Time of the Last Measurable Concentration (AUC0-t) | Up to Day 140 | AUC0-t will be assessed |
| AUC from Time 0 to Infinity (AUC0-inf) of Risankizumab | Up to Day 140 | AUC0-inf will be assessed of Risankizumab |
| Number of Anti-drug antibody (ADA) Titers | Up to Day 140 | Incidence and concentration of anti-drug antibodies |
Countries
United States
Outcome results
None listed