A Study to Assess the Relative Bioavailability of Risankizumab Following Subcutaneous Administrations With a Pre-Filled Syringe or an On-Body Injector in Healthy Adult Participants

NCT07007091 | Completed Phase 1 FDA Drug

• 1 other identifier: M25-814
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 4

Brief Summary

This study will assess the pharmacokinetics and relative Bioavailability of risankizumab following subcutaneous administration with an on-body injector relative to a prefilled syringe

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (8)

• Maximum Observed Plasma Concentration (Cmax) of Risankizumab

  Maximum observed plasma concentration (Cmax) of Risankizumab

  Up to Approximately 113 days

• Time to Cmax (Tmax) of Risankizumab

  Tmax of Risankizumab

  Up to Approximately 113 days

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

  Apparent terminal phase elimination rate constant (β) of Risankizumab

  Up to Approximately 113 days

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

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

  Up to Approximately 113 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 113 days

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

  AUCinf of Risankizumab

  Up to Approximately 113 days

• Number of Anti-drug antibodies (ADA)

  Incidence of anti-drug antibodies

  Up to Approximately 113 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 113 days

Study Arms (2)

Arm 1: Risankizumab Prefilled Syringe (PFS)

EXPERIMENTAL

Participants will receive a Subcutaneous (SC) single dose of Risankizumab PFS on Day 1

Drug: Risankizumab

Arm 2: Risankizumab On-Body Injector (OBI)

EXPERIMENTAL

Participants will receive a Subcutaneous (SC) single dose of Risankizumab OBI on Day 1

Drug: Risankizumab

Interventions

Risankizumab DRUG

Subcutaneous (SC) Injection

Arm 1: Risankizumab Prefilled Syringe (PFS)

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) is ≥ 18.0 to ≤ 32 kg/m2 after rounding to the tenths decimal at screening. BMI is calculated as weight in kg divided by the square of height measured in meters.
• Body weight between 40 kg and 100 kg, inclusive, at the time of 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 (IL)-12/23 or anti IL-23 treatment for at least one year prior to screening.
• Intention to perform strenuous exercise within one week prior to administration of study treatment and during the study confinement.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (4)

Cpmi /Id# 276490

Miami, Florida, 33172, United States

Location

Acpru /Id# 276043

Grayslake, Illinois, 60030, United States

Location

Ppd - Las Vegas Research Unit /ID# 276565

Las Vegas, Nevada, 89113, United States

Location

PPD Phase I Clinic /ID# 276525

Austin, Texas, 78744, 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: May 28, 2025
• First Posted: June 5, 2025
• Study Start: June 12, 2025
• Primary Completion: January 15, 2026
• Study Completion: January 15, 2026
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)