Trials / Completed
CompletedNCT06054425
A Study to Compare the Bioavailability of Intravenously Infused Risankizumab Manufactured by Two Different Processes in Healthy Adults
A Phase 1 Pharmacokinetic Comparability Study in Healthy Subjects to Evaluate the Relative Bioavailability of Risankizumab in Vials Manufactured by Two Different Processes
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 48 (actual)
- Sponsor
- AbbVie · Industry
- Sex
- All
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Accepted
Summary
The objective of this study is to assess the bioavailability of risankizumab liquid vial manufactured with the new process (CMC3) relative to the current process (CMC2).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Risankizumab | Infusion; intravenous |
Timeline
- Start date
- 2023-11-20
- Primary completion
- 2024-05-06
- Completion
- 2024-05-06
- First posted
- 2023-09-26
- Last updated
- 2024-05-14
Locations
3 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT06054425. Inclusion in this directory is not an endorsement.