Study of Intravenous and Subcutaneous Administration of Risankizumab in Healthy Participants

Completed · Phase 1

Conditions studied: Healthy Volunteers

In brief

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).

Key facts

Study ID

NCT05274100

Run by

AbbVie

People needed

394

Starts

2020-09-01

Expected to finish

2021-07-06

Last updated by the study team

2022-03-10

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Body weight less than 100.00 kg at Screening and upon initial confinement.

You may not qualify if…

• Previous exposure to any anti-IL-12/23 or anti-IL-23 treatment.

Where it is running

• Anaheim Clinical Trials LLC /ID# 222821 — Anaheim, California, United States
• Altasciences Clinical Los Angeles, Inc /ID# 222238 — Cypress, California, United States
• Clinical Pharmacology of Miami /ID# 225392 — Miami, Florida, United States
• PPD Clinical Research Unit /ID# 222362 — Orlando, Florida, United States
• Acpru /Id# 222349 — Grayslake, Illinois, United States
• PPD Clinical Research Unit -Las Vegas /ID# 222363 — Las Vegas, Nevada, United States
• PPD Clinical Research Unit - Austin /ID# 222361 — Austin, Texas, United States
• Spaulding Clinical Research LLC /ID# 225405 — West Bend, Wisconsin, United States

Full record on ClinicalTrials.gov

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