Status:
COMPLETED
A Study in Healthy Japanese and Caucasian Subjects to Assess the Pharmacokinetics, Safety and Tolerability of Risankizumab
Lead Sponsor:
AbbVie
Conditions:
Healthy Volunteers
Eligibility:
MALE
18-45 years
Phase:
PHASE1
Brief Summary
The main objective of this study is to assess the pharmacokinetics, safety, tolerability and immunogenicity following a single intravenous (IV) infusion of risankizumab in healthy Japanese and Caucasi...
Eligibility Criteria
Inclusion
- Must be first or second generation Japanese of full parentage residing outside of Japan for less than 10 years. First generation participants will have been born to two parents and four grandparents also born in Japan of full Japanese descent. Second generation participants born outside of Japan must have two parents and four grandparents born in Japan of full Japanese descent. All participants must maintain a typical Japanese lifestyle, including consuming a typical Japanese diet or participants must be Caucasian and not of Hispanic ethnicity.
- Body Mass Index (BMI) is \>= 18.5 and \<= 29.9 kg/m2 (after rounding to the tenths decimal) at Screening. BMI is calculated as weight in kilograms (kg) divided by the square of height measured in meters (m).
Exclusion
- Previous exposure to any anti-IL-12/23 or anti-IL-23 treatment.
- Any findings in the medical examination that are deviating from normal and judged as clinically relevant by the investigator.
- Any laboratory value outside the reference range that the investigator considers to be of clinical relevance.
- Any evidence of a concomitant disease judged as clinically relevant by the investigator.
Key Trial Info
Start Date :
October 23 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 15 2018
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT05305222
Start Date
October 23 2017
End Date
June 15 2018
Last Update
March 31 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Altasciences Clinical Los Angeles, Inc /ID# 164197
Cypress, California, United States, 90630