Risankizumab Administration Methods for Healthy Subjects

Overseen By ABBVIE CALL CENTER

Age: 18 - 65

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)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

60 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

ABBVIE INC.

Principal Investigator

AbbVie

Eligibility Criteria

This trial is for healthy adults with a BMI between 18.0 and 32.0, weighing between 40 kg and 100 kg. Participants must be in good health as determined by medical history, physical exams, vital signs, lab tests, and an ECG.

Inclusion Criteria

My BMI is between 18.0 and 32.0.

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

My weight is between 40 kg and 100 kg.

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 a single subcutaneous injection of risankizumab via prefilled syringe or pen on Day 1

1 day

1 visit (in-person)

Follow-up

Participants are monitored for pharmacokinetics, safety, and tolerability of risankizumab

20 weeks

Treatment Details

Interventions

• Risankizumab

Trial Overview The study is testing the drug Risankizumab given through a prefilled pen versus a prefilled syringe to compare how the body absorbs it (bioavailability), its safety profile, immune response it may cause (immunogenicity), and overall tolerability.

Participant Groups

Group I: Risankizumab Arm B Experimental Treatment 1 Intervention

Participants will receive a single Subcutaneous (SC) injection of risankizumab Dose B administered via Prefilled Pen (PFP) at Day 1

Group II: Risankizumab Arm A Experimental Treatment 1 Intervention

Participants will receive a single Subcutaneous (SC) injection of risankizumab Dose A administered via Prefilled Syringe (PFS) at Day 1

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