Status:
COMPLETED
A Study to Assess Pharmacokinetic Exposures Following Intravenous and Subcutaneous Administration of Risankizumab in Healthy Participants
Lead Sponsor:
AbbVie
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
The objective of this study is to compare pharmacokinetic exposures following intravenous and subcutaneous administration of Risankizumab.
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 and upon initial confinement. 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 and upon initial 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
- 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 particpant is unaccustomed within one week prior to administration of first dose of study drug and during the study.
Key Trial Info
Start Date :
July 23 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 7 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06487572
Start Date
July 23 2024
End Date
February 7 2025
Last Update
February 18 2025
Active Locations (2)
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1
Clinical Pharmacology Of Miami /ID# 268219
Miami, Florida, United States, 33014
2
Acpru /Id# 267057
Grayslake, Illinois, United States, 60030