A Study to Assess the Relative Bioavailability of Two Formulations of Risankizumab Following Subcutaneous Administration With Prefilled Syringes in Healthy Adult Participants
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Phase
Phase 1
Status
Completed
Study type
Interventional
Design
Randomized · None · Basic science
Enrollment
231actual
Sites
3
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2024-09-11 | actual | When the study began enrolling |
| Primary completion | 2025-04-16 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-04-16 | actual | The whole study's end, after follow-up |
| First posted | 2024-08-26 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-05-16 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Healthy Volunteers
Intervention
- Drug: Risankizumab — also filed as ABBV-066, SKYRIZI
Primary outcomes
what the primary-completion date above is the date OFNumber of Participants with Adverse Events (AEs)
measured Up to day 140
Maximum Observed Serum Concentration (Cmax) of Risankizumab
measured Up to Day 140
Time to Cmax (Tmax) of Risankizumab
measured Up to Day 140
Apparent Terminal Phase Elimination Rate Constant (β) of Risankizumab
measured Up to Day 140
Terminal Phase Elimination Half-life (t1/2) of Risankizumab
measured Up to Day 140
Area Under the Concentration-time Curve (AUC) from Time 0 to Time of the Last Measurable Concentration (AUC0-t)
measured Up to Day 140
AUC from Time 0 to Infinity (AUC0-inf) of Risankizumab
measured Up to Day 140
Number of Anti-drug antibody (ADA) Titers
measured Up to Day 140
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