A Study to Assess the Bioavailability of Risankizumab Following Subcutaneous Administration With Prefilled Pen Relative to a Prefilled Syringe in Healthy Adult Participants

Completed · Phase 1

Conditions studied: Healthy Volunteers

In brief

This study will assess the pharmacokinetics, relative bioavailability, immunogenicity, safety, and tolerability of risankizumab following subcutaneous (SC) administration with a prefilled pen or a prefilled syringe in healthy adult participants.

Key facts

Study ID

NCT06946524

Run by

AbbVie

People needed

59

Starts

2025-05-08

Expected to finish

2025-11-25

Last updated by the study team

2025-12-26

Who can join

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

You may qualify if…

• Body Mass Index (BMI) ≥ 18.0 to ≤ 32.0 kg/m\^2 after rounding to the tenths decimal at the time of screening and upon initial confinement. BMI is calculated as weight in kg divided by the square of height measured in meters.
• Body weight greater than 40 kg and less than 100 kg at screening and upon initial confinement.
• A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile, and a 12-lead ECG

You may not qualify if…

• Previous exposure to any anti-interleukin-12/23 or anti interleukin-23 treatment for at least one year prior to Screening.
• Intention to perform strenuous exercise to which the participant is unaccustomed within one week prior to administration of first dose of study drug and during the study.

Where it is running

• Altasciences Clinical Los Angeles /ID# 276446 — Cypress, California, United States
• Acpru /Id# 275116 — Grayslake, Illinois, United States

Full record on ClinicalTrials.gov

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