Risankizumab for Healthy Participants

Recruiting at 1 trial location

Overseen By ABBVIE CALL CENTER

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: AbbVie

Must not be taking: Anti-interleukin-12/23

Disqualifiers: Strenuous exercise, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

60 Participants Needed

Trial Summary

What is the purpose of this trial?

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

Research Team

ABBVIE INC.

Principal Investigator

AbbVie

Eligibility Criteria

This trial is for healthy individuals who want to participate in a study comparing two ways of receiving Risankizumab, a medication. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and not have conditions that could interfere with the study.

Inclusion Criteria

My weight is between 40 kg and 100 kg.

My overall health is good based on recent medical exams.

My BMI is between 18.0 and 32.0.

Exclusion Criteria

I have been treated with anti-IL-12/23 or anti-IL-23 drugs for over a year.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either intravenous or subcutaneous administration of Risankizumab

4 weeks

Follow-up

Participants are monitored for safety and pharmacokinetic outcomes after treatment

140 days

Treatment Details

Interventions

• Risankizumab

Trial Overview The focus of this trial is on how the body absorbs Risankizumab when it's given through an IV (intravenous) versus as a shot under the skin (subcutaneous). The goal is to understand differences in drug levels in the bloodstream with these methods.

Participant Groups

Group I: Risankizumab Dose B for Subcutaneous (SC) Injection Experimental Treatment 1 Intervention

Participants will receive SC injections of risankizumab at dose B and then followed for 140 days.

Group II: Risankizumab Dose A for Intravenous (IV) Infusion Experimental Treatment 1 Intervention

Participants will receive IV infusion of risankizumab at dose A and then followed for 140 days.

Risankizumab is already approved in Canada, United States, European Union for the following indications:

Approved in Canada as Skyrizi for:

• Moderate-to-severe Crohn's disease

Approved in United States as Skyrizi for:

• Moderate-to-severe Crohn's disease
• Moderate-to-severe plaque psoriasis

Approved in European Union as Skyrizi for:

• Moderate-to-severe Crohn's disease
• Moderate-to-severe plaque psoriasis
• Psoriatic arthritis

Who Is Running the Clinical Trial?

AbbVie

Lead Sponsor

Trials

1,079

Recruited

535,000+

Founded

2013

Headquarters

North Chicago, USA

Known For

Immunology treatments

Top Products

Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois