Status:
COMPLETED
A Study to Evaluate the Bioavailability of Risankizumab Following Subcutaneous Dosing in Healthy Male Participants
Lead Sponsor:
AbbVie
Conditions:
Healthy Volunteers
Eligibility:
MALE
18-55 years
Phase:
PHASE1
Brief Summary
The objective of this study is to evaluate the bioavailability, safety and tolerability of risankizumab following subcutaneous injections in healthy male participants.
Eligibility Criteria
Inclusion
- Body weight less than 100.00 kg inclusive at Screening and Check-In Day.
- Body Mass Index (BMI) is ≥ 18.0 to ≤ 29.9 kg/m2 after rounded to the tenths decimal, at Screening and upon confinement.
Exclusion
- Previous exposure to any anti-IL-12/23 or anti-IL-23 treatment.
- History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma), renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.
Key Trial Info
Start Date :
September 11 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 12 2018
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT05283694
Start Date
September 11 2017
End Date
June 12 2018
Last Update
March 17 2022
Active Locations (1)
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1
Acpru /Id# 165737
Grayslake, Illinois, United States, 60030