231 Participants Needed

Risankizumab for Healthy Subjects

Recruiting at 2 trial locations
AC
Overseen ByABBVIE CALL CENTER
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

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

AI

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
3Treatment groups
Experimental Treatment
Group I: Risankizumab Formulation 3Experimental Treatment1 Intervention
Participants will receive a single dose of Risankizumab formulation 3 on day 1.
Group II: Risankizumab Formulation 2Experimental Treatment1 Intervention
Participants will receive a single dose of Risankizumab formulation 2 on day 1.
Group III: Risankizumab Formulation 1Experimental Treatment1 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:

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Approved in Canada as Skyrizi for:
  • Moderate-to-severe Crohn's disease
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Approved in United States as Skyrizi for:
  • Moderate-to-severe Crohn's disease
  • Moderate-to-severe plaque psoriasis
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Approved in European Union as Skyrizi for:
  • Moderate-to-severe Crohn's disease
  • Moderate-to-severe plaque psoriasis
  • Psoriatic arthritis

Find a Clinic Near You

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 profile image

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

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