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

Phase 1

Not yet recruiting

• Conditions: Healthy Volunteers
• Interventions: Drug: Risankizumab

• Registration Number: NCT07007091
• Lead Sponsor: AbbVie

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-05-28
• Study First Submitted QC: 2025-05-28
• Status Verified: 2025-06
• Study Start: 2025-06-02
• Study First Posted: 2025-06-05
• Last Update Submitted: 2025-06-09
• Last Update Posted: 2025-06-10
• Primary Completion: 2025-11
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 252

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1: Risankizumab Prefilled Syringe (PFS)	Risankizumab	Participants will receive a Subcutaneous (SC) single dose of Risankizumab PFS on Day 1
Arm 2: Risankizumab On-Body Injector (OBI)	Risankizumab	Participants will receive a Subcutaneous (SC) single dose of Risankizumab OBI on Day 1

Primary Outcome Measures

Name	Time	Method
Number of Anti-drug antibodies (ADA)	Up to Approximately 113 days	Incidence of anti-drug antibodies
Time to Cmax (Tmax) of Risankizumab	Up to Approximately 113 days	Tmax of Risankizumab
Maximum Observed Plasma Concentration (Cmax) of Risankizumab	Up to Approximately 113 days	Maximum observed plasma concentration (Cmax) of Risankizumab
Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to the Last Measurable Concentration (AUCt) of Risankizumab	Up to Approximately 113 days	AUCt of Risankizumab
Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Infinity (AUCinf) of Risankizumab	Up to Approximately 113 days	AUCinf of Risankizumab
Apparent Terminal Phase Elimination Rate Constant (β) of Risankizumab	Up to Approximately 113 days	Apparent terminal phase elimination rate constant (β) of Risankizumab
Terminal Phase Elimination Half-life (t1/2) of Risankizumab	Up to Approximately 113 days	Terminal phase elimination half-life (t1/2) of Risankizumab
Number of Participants Experiencing Adverse Events	Up to Approximately 113 days	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

Trial Locations

Locations (3)

Cpmi /Id# 276490; 🇺🇸 Miami, Florida, United States

Acpru /Id# 276043; 🇺🇸 Grayslake, Illinois, United States

PPD Phase I Clinic /ID# 276525; 🇺🇸 Austin, Texas, United States