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

A Phase 1 Pharmacokinetic Study in Healthy Subjects to Evaluate the Relative Bioavailability of Two Formulations of Risankizumab Following Subcutaneous Administration With Prefilled Syringes

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

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 231
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Anaheim, California, United States, 92801
      • Cenexel Act /ID# 270310
    • Los Alamitos, California, United States, 90720
      • Collaborative Neuroscience Research CNS /ID# 270286
  • Illinois
    • Grayslake, Illinois, United States, 60030
      • Acpru /Id# 270152

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

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

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Risankizumab Formulation 1; Participants will receive a single dose of Risankizumab formulation 1 on day 1.	Drug: Risankizumab; • Subcutaneous Injection via prefilled syringe; Other Names: ABBV-066; SKYRIZI
Experimental: Risankizumab Formulation 2; Participants will receive a single dose of Risankizumab formulation 2 on day 1.	Drug: Risankizumab; • Subcutaneous Injection via prefilled syringe; Other Names: ABBV-066; SKYRIZI
Experimental: Risankizumab Formulation 3; Participants will receive a single dose of Risankizumab formulation 3 on day 1.	Drug: Risankizumab; • Subcutaneous Injection via prefilled syringe; Other Names: ABBV-066; SKYRIZI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Adverse Events (AEs)	An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.	Up to day 140
Maximum Observed Serum Concentration (Cmax) of Risankizumab	Cmax will be assessed of Risankizumab	Up to Day 140
Time to Cmax (Tmax) of Risankizumab	Tmax will be assessed of Risankizumab	Up to Day 140
Apparent Terminal Phase Elimination Rate Constant (β) of Risankizumab	Apparent terminal phase elimination rate constant (β) will be assessed of Risankizumab	Up to Day 140
Terminal Phase Elimination Half-life (t1/2) of Risankizumab	Terminal phase elimination half-life (t1/2) will be assessed of Risankizumab	Up to Day 140
Area Under the Concentration-time Curve (AUC) from Time 0 to Time of the Last Measurable Concentration (AUC0-t)	AUC0-t will be assessed	Up to Day 140
AUC from Time 0 to Infinity (AUC0-inf) of Risankizumab	AUC0-inf will be assessed of Risankizumab	Up to Day 140
Number of Anti-drug antibody (ADA) Titers	Incidence and concentration of anti-drug antibodies	Up to Day 140

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): September 11, 2024
• Primary Completion (Actual): April 16, 2025
• Study Completion (Actual): April 16, 2025

Study Registration Dates

• First Submitted: August 23, 2024
• First Submitted That Met QC Criteria: August 23, 2024
• First Posted (Actual): August 26, 2024

Study Record Updates

• Last Update Posted (Actual): May 16, 2025
• Last Update Submitted That Met QC Criteria: May 14, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Healthy Volunteers; Risankizumab; ABBV-066
• Other Study ID Numbers: M24-342

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