A Study to Assess How Intravenous and Subcutaneous Administrations of Risankizumab Moves Through the Body of Healthy Adult Participants
Purpose
The purpose of this study is to compare how the drug moves through the body following risankizumab subcutaneous (SC) and risankizumab intravenous (IV) doses.
Condition
- Healthy Volunteer
Eligibility
- Eligible Ages
- Between 18 Years and 65 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Body weight between 40 kg and 100 kg inclusive at screening and upon initial confinement. - BMI is ≥ 18.0 to ≤ 32.0 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. - 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
- 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 subject is unaccustomed within one week prior to administration of first dose of study treatment or during the study.
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Basic Science
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Risankizumab Dose A |
Participants will receive Dose A of risankizumab via intravenous (IV) infusion. |
|
|
Experimental Risankizumab Dose B |
Participants will receive Dose B of risankizumab via subcutaneous (SC) injection. |
|
Recruiting Locations
CenExel ACT- Anaheim Clinical Trials /ID# 281821
Anaheim, California 92801
Anaheim, California 92801
Cpmi /Id# 281783
Miami, Florida 33172
Miami, Florida 33172
More Details
- Status
- Recruiting
- Sponsor
- AbbVie