Risankizumab for Healthy Subjects

Recruiting at 2 trial locations

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: Epilepsy, Cardiac, Respiratory, 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: 1

Duration: 1 day

231 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will assess the pharmacokinetics, relative bioavailability and tolerability of two formulations of risankizumab following subcutaneous (SC) administration in healthy adult participants.

Research Team

ABBVIE INC.

Principal Investigator

AbbVie

Eligibility Criteria

Inclusion Criteria

My weight is between 40 and 100 kg.

My BMI is between 18.0 and 32.0.

I am generally healthy based on recent medical exams.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of one of three formulations of Risankizumab on day 1

1 day

1 visit (in-person)

Follow-up

Participants are monitored for pharmacokinetics, relative bioavailability, and tolerability, with assessments up to day 140

20 weeks

Treatment Details

Interventions

• Risankizumab

Participant Groups

Group I: Risankizumab Formulation 3 Experimental Treatment 1 Intervention

Participants will receive a single dose of Risankizumab formulation 3 on day 1.

Group II: Risankizumab Formulation 2 Experimental Treatment 1 Intervention

Participants will receive a single dose of Risankizumab formulation 2 on day 1.

Group III: Risankizumab Formulation 1 Experimental Treatment 1 Intervention

Participants will receive a single dose of Risankizumab formulation 1 on day 1.

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