A Study to Assess Pharmacokinetic Exposures Following Intravenous and Subcutaneous Administration of Risankizumab in Healthy Participants
Part of paid clinical trials in Miami, Florida.
- Sponsor
- AbbVie
- Study ID
- NCT06487572
- Phase
- PHASE1
- Status
- Completed
Conditions
- Healthy Volunteers
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 65 Years
- Healthy Volunteers
- Accepted
Interventions
- Risankizumab — DRUGIntravenous (IV) Infusion
- Risankizumab — DRUGSubcutaneous (SC) Injection
Study Details
The objective of this study is to compare pharmacokinetic exposures following intravenous and subcutaneous administration of Risankizumab.
Key Dates
- Start date
- Jul 23, 2024
- Status verified
- Feb 2025
- Primary completion
- Feb 7, 2025
- Completion
- Feb 7, 2025
Study Design
- Enrollment
- 60 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- BASIC_SCIENCE
Arms
- Experimental: Risankizumab Dose A for Intravenous (IV) InfusionParticipants will receive IV infusion of risankizumab at dose A and then followed for 140 days.
- Experimental: Risankizumab Dose B for Subcutaneous (SC) InjectionParticipants will receive SC injections of risankizumab at dose B and then followed for 140 days.
Primary Outcome Measure
Number of Participants Experiencing Adverse Events [ Time Frame: Up to approximately 140 days ]
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Clinical Pharmacology Of Miami /ID# 268219 | Miami | Florida | 33014 | - |
| Acpru /Id# 267057 | Grayslake | Illinois | 60030 | - |
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