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

NCT06571266 | Completed Phase 1

• 1 other identifier: M24-342
• Study Type: interventional
• Target: 231
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Healthy Volunteers

Keywords

Healthy Volunteers; Risankizumab; ABBV-066

Outcome Measures

Primary Outcomes (8)

• 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

Study Arms (3)

Risankizumab Formulation 1

EXPERIMENTAL

Participants will receive a single dose of Risankizumab formulation 1 on day 1.

Drug: Risankizumab

Risankizumab Formulation 2

EXPERIMENTAL

Participants will receive a single dose of Risankizumab formulation 2 on day 1.

Drug: Risankizumab

Risankizumab Formulation 3

EXPERIMENTAL

Participants will receive a single dose of Risankizumab formulation 3 on day 1.

Drug: Risankizumab

Interventions

Risankizumab DRUG

• Subcutaneous Injection via prefilled syringe

Also known as: ABBV-066, SKYRIZI

Risankizumab Formulation 1; Risankizumab Formulation 2; Risankizumab Formulation 3

Eligibility Criteria

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

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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (3)

Cenexel Act /ID# 270310

Anaheim, California, 92801, United States

Location

Collaborative Neuroscience Research CNS /ID# 270286

Los Alamitos, California, 90720, United States

Location

Acpru /Id# 270152

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: August 23, 2024
• First Posted: August 26, 2024
• Study Start: September 11, 2024
• Primary Completion: April 16, 2025
• Study Completion: April 16, 2025
• Last Updated: May 16, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)