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

NCT06937619 | Completed Phase 1 FDA Drug

• 1 other identifier: M24-920
• Study Type: interventional
• Target: 263
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Healthy Volunteer

Keywords

Healthy Volunteer; Risankizumab; ABBV-066; SKYRIZI

Outcome Measures

Primary Outcomes (8)

• 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 Anti-drug antibody (ADA) Titers

  Incidence and concentration of anti-drug antibodies

  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

Study Arms (2)

Risankizumab Arm A

EXPERIMENTAL

Participants will receive a single dose of Risankizumab On-Body Injector (OBI) produced by new process on Day 1.

Drug: Risankizumab

Risankizumab Arm B

EXPERIMENTAL

Participants will receive a single dose of Risankizumab On-Body Injector (OBI) produced by current process on Day 1.

Drug: Risankizumab

Interventions

Risankizumab DRUG

Subcutaneous Injection

Also known as: SKYRIZI, ABBV-066

Risankizumab Arm A; Risankizumab Arm B

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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. 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

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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (4)

CenExel ACT- Anaheim Clinical Trials /ID# 274805

Anaheim, California, 92801, United States

Location

Collaborative Neuroscience Research CNS /ID# 275212

Los Alamitos, California, 90720, United States

Location

Cpmi /Id# 274464

Miami, Florida, 33172, United States

Location

Acpru /Id# 271954

Grayslake, Illinois, 60030, United States

Location

Related Links

• Related Info

MeSH Terms

Interventions

risankizumab

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2025
• First Posted: April 22, 2025
• Study Start: April 21, 2025
• Primary Completion: November 10, 2025
• Study Completion: November 10, 2025
• Last Updated: November 17, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)