Risankizumab for Healthy Subjects
Recruiting at 2 trial locations
AC
Overseen ByABBVIE CALL CENTER
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Waitlist Available
Sponsor: AbbVie
No Placebo Group
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?
This study will assess the pharmacokinetics, relative bioavailability and tolerability of two formulations of risankizumab following subcutaneous (SC) administration in healthy adult participants.
Research Team
AI
ABBVIE INC.
Principal Investigator
AbbVie
Eligibility Criteria
Inclusion Criteria
My weight is between 40 and 100 kg.
My BMI is between 18.0 and 32.0.
I am generally healthy based on recent medical exams.
Treatment Details
Interventions
- Risankizumab (Monoclonal Antibodies)
Participant Groups
3Treatment groups
Experimental Treatment
Group I: Risankizumab Formulation 3Experimental Treatment1 Intervention
Participants will receive a single dose of Risankizumab formulation 3 on day 1.
Group II: Risankizumab Formulation 2Experimental Treatment1 Intervention
Participants will receive a single dose of Risankizumab formulation 2 on day 1.
Group III: Risankizumab Formulation 1Experimental Treatment1 Intervention
Participants will receive a single dose of Risankizumab formulation 1 on day 1.
Risankizumab is already approved in Canada for the following indications:
Approved in Canada as Skyrizi for:
- Moderate-to-severe Crohn's disease
Find a Clinic Near You
Who Is Running the Clinical Trial?
AbbVie
Lead Sponsor
Trials
1,079
Recruited
535,000+
Founded
2013
Headquarters
North Chicago, USA
Known For
Immunology treatments
Top Products
Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)
Dr. Roopal Thakkar
AbbVie
Chief Medical Officer since 2023
MD from Wayne State University School of Medicine
Robert A. Michael
AbbVie
Chief Executive Officer
Bachelor's degree in Finance from the University of Illinois