A Study to Assess Pharmacokinetic Exposures Following Intravenous and Subcutaneous Administration of Risankizumab in Healthy Participants

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: Risankizumab

• Registration Number: NCT06487572
• Lead Sponsor: AbbVie

Brief Summary

The objective of this study is to compare pharmacokinetic exposures following intravenous and subcutaneous administration of Risankizumab.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-06-28
• Study First Submitted QC: 2024-06-28
• Study First Posted: 2024-07-05
• Study Start: 2024-07-23
• Status Verified: 2025-02
• Primary Completion: 2025-02-07
• Study Completion: 2025-02-07
• Last Update Submitted: 2025-02-17
• Last Update Posted: 2025-02-18

Recruitment & Eligibility

• Status: COMPLETED
• 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 particpant 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 Dose B for Subcutaneous (SC) Injection	Risankizumab	Participants will receive SC injections of risankizumab at dose B and then followed for 140 days.
Risankizumab Dose A for Intravenous (IV) Infusion	Risankizumab	Participants will receive IV infusion of risankizumab at dose A and then followed for 140 days.

Primary Outcome Measures

Name	Time	Method
Area Under the Serum Concentration-Time Curve (AUC) of Risankizumab	Up to approximately Week 4	AUCt of Risankizumab.
Number of Participants Experiencing Adverse Events	Up to approximately 140 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 Serum Concentration (Cmax) of Risankizumab	Up to approximately 140 days	Cmax of Risankizumab.
Time to Cmax (Tmax) of Risankizumab	Up to approximately 140 days	Tmax of Risankizumab.

Trial Locations

Locations (2)

Clinical Pharmacology Of Miami /ID# 268219; 🇺🇸 Miami, Florida, United States

Acpru /Id# 267057; 🇺🇸 Grayslake, Illinois, United States