A Study to Assess the Relative Bioavailability of Two Formulations of Risankizumab Following Subcutaneous Administration With Prefilled Syringes in Healthy Adult Participants

Completed · Phase 1

Conditions studied: Healthy Volunteers

In brief

This study will assess the pharmacokinetics, relative bioavailability and tolerability of two formulations of risankizumab following subcutaneous (SC) administration in healthy adult participants.

Key facts

Study ID

NCT06571266

Run by

AbbVie

People needed

231

Starts

2024-09-11

Expected to finish

2025-04-16

Last updated by the study team

2025-05-16

Who can join

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

You may qualify if…

• Body weight 40 kg to 100 kg, inclusive, at screening and upon initial confinement
• Body Mass Index (BMI) is > = 18.0 to < = 32.0 kg/m2 after rounded to the tenths decimal, at Screening and upon 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…

• Participant with exposure to any anti-interleukin-12/23 or anti-interleukin-23 treatment for at least one year prior to Screening.
• Participant with intention to perform strenuous exercise within at least one week prior to administration of study drug or during the study.
• History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.

Where it is running

• Cenexel Act /ID# 270310 — Anaheim, California, United States
• Collaborative Neuroscience Research CNS /ID# 270286 — Los Alamitos, California, United States
• Acpru /Id# 270152 — Grayslake, Illinois, United States

Full record on ClinicalTrials.gov

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