A Study to Assess the Relative Bioavailability of Risankizumab Following Subcutaneous Administration With On-Body Injector in Healthy Adult Participants

A Phase 1 Pharmacokinetic Study in Healthy Subjects to Evaluate the Relative Bioavailability of Risankizumab Following Subcutaneous Administration With On-Body Injector

This study will assess the pharmacokinetics and relative Bioavailability of risankizumab following subcutaneous (SC) administration with on-body Injector in Healthy Adult Participants.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteer
• Intervention / Treatment: Drug: Risankizumab

• Study Type: Interventional
• Enrollment (Actual): 263
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Anaheim, California, United States, 92801
      • CenExel ACT- Anaheim Clinical Trials /ID# 274805
    • Los Alamitos, California, United States, 90720
      • Collaborative Neuroscience Research CNS /ID# 275212
  • Florida
    • Miami, Florida, United States, 33172
      • Cpmi /Id# 274464
  • Illinois
    • Grayslake, Illinois, United States, 60030
      • Acpru /Id# 271954

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Body Mass Index (BMI) ≥ 18.0 to ≤ 32.0 kg/m^2 after rounding to the tenths decimal at the time of screening. 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.
• 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Risankizumab Arm A; Participants will receive a single dose of Risankizumab On-Body Injector (OBI) produced by new process on Day 1.	Drug: Risankizumab; Subcutaneous Injection; Other Names: ABBV-066; SKYRIZI
Experimental: Risankizumab Arm B; Participants will receive a single dose of Risankizumab On-Body Injector (OBI) produced by current process on Day 1.	Drug: Risankizumab; Subcutaneous Injection; Other Names: ABBV-066; SKYRIZI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Observed Plasma Concentration (Cmax) of Risankizumab	Maximum observed plasma concentration (Cmax) of Risankizumab	Up to approximately 140 days
Time to Cmax (Tmax) of Risankizumab	Tmax of Risankizumab	Up to approximately 140 days
Apparent Terminal Phase Elimination Rate Constant (β) of Risankizumab	Apparent terminal phase elimination rate constant (β) of Risankizumab	Up to approximately 140 days
Terminal Phase Elimination Half-life (t1/2) of Risankizumab	Terminal phase elimination half-life (t1/2) of Risankizumab	Up to approximately 140 days
Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to the Last Measurable Concentration (AUCt) of Risankizumab	AUCt of Risankizumab	Up to approximately 140 days
Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Infinity (AUCinf) of Risankizumab	AUCinf of Risankizumab	Up to approximately 140 days
Number of Participants Experiencing Adverse Events	An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment	Up to approximately 140 days
Number of Anti-drug antibody (ADA) Titers	Incidence and concentration of anti-drug antibodies	Up to approximately 140 days

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): April 21, 2025
• Primary Completion (Actual): November 10, 2025
• Study Completion (Actual): November 10, 2025

Study Registration Dates

• First Submitted: April 4, 2025
• First Submitted That Met QC Criteria: April 18, 2025
• First Posted (Actual): April 22, 2025

Study Record Updates

• Last Update Posted (Actual): November 17, 2025
• Last Update Submitted That Met QC Criteria: November 14, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Healthy Volunteer; Risankizumab; ABBV-066; SKYRIZI
• Additional Relevant MeSH Terms: risankizumab
• Other Study ID Numbers: M24-920

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No