Status:
COMPLETED
A Study to Assess the Relative Bioavailability of Two Formulations of Risankizumab Following Subcutaneous Administration With Prefilled Syringes in Healthy Adult Participants
Lead Sponsor:
AbbVie
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
This study will assess the pharmacokinetics, relative bioavailability and tolerability of two formulations of risankizumab following subcutaneous (SC) administration in healthy adult participants.
Eligibility Criteria
Inclusion
- Body weight 40 kg to 100 kg, inclusive, at screening and upon initial confinement
- Body Mass Index (BMI) is \> = 18.0 to \< = 32.0 kg/m2 after rounded to the tenths decimal, at Screening and upon 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
- Participant with exposure to any anti-interleukin-12/23 or anti-interleukin-23 treatment for at least one year prior to Screening.
- Participant with intention to perform strenuous exercise within at least one week prior to administration of study drug or during the study.
- History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.
Key Trial Info
Start Date :
September 11 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 16 2025
Estimated Enrollment :
231 Patients enrolled
Trial Details
Trial ID
NCT06571266
Start Date
September 11 2024
End Date
April 16 2025
Last Update
May 16 2025
Active Locations (3)
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1
Cenexel Act /ID# 270310
Anaheim, California, United States, 92801
2
Collaborative Neuroscience Research CNS /ID# 270286
Los Alamitos, California, United States, 90720
3
Acpru /Id# 270152
Grayslake, Illinois, United States, 60030