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

Phase 1

Recruiting

• Conditions: Healthy Volunteers
• Interventions: Drug: Risankizumab

• Registration Number: NCT06946524
• Lead Sponsor: AbbVie

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-04-21
• Study First Submitted QC: 2025-04-21
• Study First Posted: 2025-04-27
• Status Verified: 2025-05
• Study Start: 2025-05-08
• Last Update Submitted: 2025-05-22
• Last Update Posted: 2025-05-26
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Risankizumab Arm A	Risankizumab	Participants will receive a single Subcutaneous (SC) injection of risankizumab Dose A administered via Prefilled Syringe (PFS) at Day 1
Risankizumab Arm B	Risankizumab	Participants will receive a single Subcutaneous (SC) injection of risankizumab Dose B administered via Prefilled Pen (PFP) at Day 1

Primary Outcome Measures

Name	Time	Method
Number of Participants Experiencing Adverse Events	Up to approximately 141 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
Maximum Observed Plasma Concentration (Cmax) of Risankizumab	Up to approximately 141 days	Maximum observed plasma concentration (Cmax) of Risankizumab
Time to Cmax (Tmax) of Risankizumab	Up to approximately 141 days	Tmax of Risankizumab
Apparent Terminal Phase Elimination Rate Constant (β) of Risankizumab	Up to approximately 141 days	Apparent terminal phase elimination rate constant (β) of Risankizumab
Terminal Phase Elimination Half-life (t1/2) of Risankizumab	Up to approximately 141 days	Terminal phase elimination half-life (t1/2) of Risankizumab
Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to the Last Measurable Concentration (AUCt) of Risankizumab	Up to approximately 141 days	AUCt of Risankizumab
Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Infinity (AUCinf) of Risankizumab	Up to approximately 141 days	AUCinf of Risankizumab

Trial Locations

Locations (1)

Altasciences Clinical Los Angeles /ID# 276446; 🇺🇸 Cypress, California, United States