A Study to Assess the Bioavailability of Risankizumab Following Subcutaneous Administration With Prefilled Pen Relative to a Prefilled Syringe in Healthy Adult Participants

NCT06946524 | Completed Phase 1 FDA Drug

• 1 other identifier: M25-681
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 2

Brief Summary

This study will assess the pharmacokinetics, relative bioavailability, immunogenicity, safety, and tolerability of risankizumab following subcutaneous (SC) administration with a prefilled pen or a prefilled syringe in healthy adult participants.

Conditions

Healthy Volunteers

Keywords

Healthy Volunteers; Risankizumab

Outcome Measures

Primary Outcomes (7)

• Maximum Observed Plasma Concentration (Cmax) of Risankizumab

  Maximum observed plasma concentration (Cmax) of Risankizumab

  Up to approximately 141 days

• Time to Cmax (Tmax) of Risankizumab

  Tmax of Risankizumab

  Up to approximately 141 days

• Apparent Terminal Phase Elimination Rate Constant (β) of Risankizumab

  Apparent terminal phase elimination rate constant (β) of Risankizumab

  Up to approximately 141 days

• Terminal Phase Elimination Half-life (t1/2) of Risankizumab

  Terminal phase elimination half-life (t1/2) of Risankizumab

  Up to approximately 141 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 141 days

• Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Infinity (AUCinf) of Risankizumab

  AUCinf of Risankizumab

  Up to approximately 141 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 141 days

Study Arms (2)

Risankizumab Arm A

EXPERIMENTAL

Participants will receive a single Subcutaneous (SC) injection of risankizumab Dose A administered via Prefilled Syringe (PFS) at Day 1

Drug: Risankizumab

Risankizumab Arm B

EXPERIMENTAL

Participants will receive a single Subcutaneous (SC) injection of risankizumab Dose B administered via Prefilled Pen (PFP) at Day 1

Drug: Risankizumab

Interventions

Risankizumab DRUG

Subcutaneous Injection

Also known as: SKYRIZI

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 and upon initial confinement. 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 and upon initial 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:

• 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 (2)

Altasciences Clinical Los Angeles /ID# 276446

Cypress, California, 90630, United States

Location

Acpru /Id# 275116

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 21, 2025
• First Posted: April 27, 2025
• Study Start: May 8, 2025
• Primary Completion: November 25, 2025
• Study Completion: November 25, 2025
• Last Updated: December 26, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)