Trials / Completed
CompletedNCT05274100
Study of Intravenous and Subcutaneous Administration of Risankizumab in Healthy Participants
A Phase 1, Pharmacokinetic Comparability Study of Intravenous and Subcutaneous Administration of Risankizumab in Healthy Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 394 (actual)
- Sponsor
- AbbVie · Industry
- Sex
- All
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Accepted
Summary
The primary objectives of this study are to assess the relative bioavailability of risankizumab in on-body delivery system (OBDS) versus the prefilled syringe (PFS) (Substudy 1) and to assess the relative bioavailability of risankizumab in the to-be-marketed Dose A liquid vial versus the Dose B liquid vial used in the Phase 3 studies (Substudy 2).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Risankizumab | Subcutaneous Injection via prefilled syringe (PFS) |
| DRUG | Risankizumab | Intravenous Infusion |
| DRUG | Risankizumab | Subcutaneous Injection via on-body delivery system (OBDS) |
Timeline
- Start date
- 2020-09-01
- Primary completion
- 2021-07-06
- Completion
- 2021-07-06
- First posted
- 2022-03-10
- Last updated
- 2022-03-10
Locations
8 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05274100. Inclusion in this directory is not an endorsement.