A Study to Evaluate the Bioavailability of Risankizumab in Pre-filled Syringe or Auto-injector in Healthy Adult Participants

Completed · Phase 1

Conditions studied: Healthy Volunteers

In brief

The objective of this study is to evaluate the bioavailability of risankizumab new formulation in prefilled syringe (PFS) relative to the 90 mg/mL formulation in PFS in healthy volunteers. The study will also evaluate the bioavailability of risankizumab new formulation in auto-injector (AI) relative to PFS in healthy volunteers.

Key facts

Study ID

NCT05283681

Run by

AbbVie

People needed

226

Starts

2019-04-02

Expected to finish

2019-11-11

Last updated by the study team

2022-03-17

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Male and female healthy volunteers between 18 and 55 years of age.
• Body weight less than 110.00 kg inclusive at Screening.

You may not qualify if…

• Previous exposure to any anti-IL-12/23 or anti-IL-23 treatment.
• Intention to perform strenuous exercise to which the subject is unaccustomed within one week prior to administration of study drug or during the study.

Where it is running

• Acpru /Id# 210844 — Grayslake, Illinois, United States
• PPD Clinical Research Unit - Austin /ID# 211456 — Austin, Texas, United States

Full record on ClinicalTrials.gov

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