Status:
COMPLETED
A Study to Evaluate the Bioavailability of Risankizumab in Pre-filled Syringe or Auto-injector in Healthy Adult Participants
Lead Sponsor:
AbbVie
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The objective of this study is to evaluate the bioavailability of risankizumab new formulation in prefilled syringe (PFS) relative to the 90 mg/mL formulation in PFS in healthy volunteers. The study w...
Eligibility Criteria
Inclusion
- Male and female healthy volunteers between 18 and 55 years of age.
- Body weight less than 110.00 kg inclusive at Screening.
Exclusion
- Previous exposure to any anti-IL-12/23 or anti-IL-23 treatment.
- Intention to perform strenuous exercise to which the subject is unaccustomed within one week prior to administration of study drug or during the study.
Key Trial Info
Start Date :
April 2 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 11 2019
Estimated Enrollment :
226 Patients enrolled
Trial Details
Trial ID
NCT05283681
Start Date
April 2 2019
End Date
November 11 2019
Last Update
March 17 2022
Active Locations (2)
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1
Acpru /Id# 210844
Grayslake, Illinois, United States, 60030
2
PPD Clinical Research Unit - Austin /ID# 211456
Austin, Texas, United States, 78744