Status:
COMPLETED
A Study to Assess the Relative Bioavailability of Risankizumab Following Subcutaneous Administration With On-Body Injector in Healthy Adult Participants
Lead Sponsor:
AbbVie
Conditions:
Healthy Volunteer
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
This study will assess the pharmacokinetics and relative Bioavailability of risankizumab following subcutaneous (SC) administration with on-body Injector in Healthy Adult Participants.
Eligibility Criteria
Inclusion
- Body Mass Index (BMI) ≥ 18.0 to ≤ 32.0 kg/m\^2 after rounding to the tenths decimal at the time of screening. 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.
- 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
- 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.
Key Trial Info
Start Date :
April 21 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 10 2025
Estimated Enrollment :
263 Patients enrolled
Trial Details
Trial ID
NCT06937619
Start Date
April 21 2025
End Date
November 10 2025
Last Update
November 17 2025
Active Locations (4)
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1
CenExel ACT- Anaheim Clinical Trials /ID# 274805
Anaheim, California, United States, 92801
2
Collaborative Neuroscience Research CNS /ID# 275212
Los Alamitos, California, United States, 90720
3
Cpmi /Id# 274464
Miami, Florida, United States, 33172
4
Acpru /Id# 271954
Grayslake, Illinois, United States, 60030