Study of Intravenous and Subcutaneous Administration of Risankizumab in Healthy Participants

March 8, 2022 updated by: AbbVie

A Phase 1, Pharmacokinetic Comparability Study of Intravenous and Subcutaneous Administration of Risankizumab in Healthy Subjects

The primary objectives of this study are to assess the relative bioavailability of risankizumab in on-body delivery system (OBDS) versus the prefilled syringe (PFS) (Substudy 1) and to assess the relative bioavailability of risankizumab in the to-be-marketed Dose A liquid vial versus the Dose B liquid vial used in the Phase 3 studies (Substudy 2).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

394

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Anaheim, California, United States, 92801-2658
        • Anaheim Clinical Trials LLC /ID# 222821
      • Cypress, California, United States, 90630
        • Altasciences Clinical Los Angeles, Inc /ID# 222238
    • Florida
      • Miami, Florida, United States, 33014
        • Clinical Pharmacology of Miami /ID# 225392
      • Orlando, Florida, United States, 32806-1044
        • PPD Clinical Research Unit /ID# 222362
    • Illinois
      • Grayslake, Illinois, United States, 60030
        • Acpru /Id# 222349
    • Nevada
      • Las Vegas, Nevada, United States, 89113-2235
        • PPD Clinical Research Unit -Las Vegas /ID# 222363
    • Texas
      • Austin, Texas, United States, 78744
        • PPD Clinical Research Unit - Austin /ID# 222361
    • Wisconsin
      • West Bend, Wisconsin, United States, 53095
        • Spaulding Clinical Research LLC /ID# 225405

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

- Body weight less than 100.00 kg at Screening and upon initial confinement.

Exclusion Criteria:

- Previous exposure to any anti-IL-12/23 or anti-IL-23 treatment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Group 1: Risankizumab Dose A
Participants will receive risankizumab dose A.
Drug: Risankizumab
Subcutaneous Injection via prefilled syringe (PFS)
Other Names:
  • SKYRIZI
Drug: Risankizumab
Intravenous Infusion
Other Names:
  • SKYRIZI
Drug: Risankizumab
Subcutaneous Injection via on-body delivery system (OBDS)
Other Names:
  • SKYRIZI
EXPERIMENTAL: Group 2: Risankizumab Dose B
Participants will receive risankizumab dose B.
Drug: Risankizumab
Subcutaneous Injection via prefilled syringe (PFS)
Other Names:
  • SKYRIZI
Drug: Risankizumab
Intravenous Infusion
Other Names:
  • SKYRIZI
Drug: Risankizumab
Subcutaneous Injection via on-body delivery system (OBDS)
Other Names:
  • SKYRIZI
EXPERIMENTAL: Group 3: Risankizumab Dose C
Participants will receive risankizumab dose C.
Drug: Risankizumab
Subcutaneous Injection via prefilled syringe (PFS)
Other Names:
  • SKYRIZI
Drug: Risankizumab
Intravenous Infusion
Other Names:
  • SKYRIZI
Drug: Risankizumab
Subcutaneous Injection via on-body delivery system (OBDS)
Other Names:
  • SKYRIZI
EXPERIMENTAL: Group 4: Risankizumab Dose D
Participants will receive risankizumab dose D.
Drug: Risankizumab
Subcutaneous Injection via prefilled syringe (PFS)
Other Names:
  • SKYRIZI
Drug: Risankizumab
Intravenous Infusion
Other Names:
  • SKYRIZI
Drug: Risankizumab
Subcutaneous Injection via on-body delivery system (OBDS)
Other Names:
  • SKYRIZI
EXPERIMENTAL: Group 5: Risankizumab Dose D
Participants will receive risankizumab dose D.
Drug: Risankizumab
Subcutaneous Injection via prefilled syringe (PFS)
Other Names:
  • SKYRIZI
Drug: Risankizumab
Intravenous Infusion
Other Names:
  • SKYRIZI
Drug: Risankizumab
Subcutaneous Injection via on-body delivery system (OBDS)
Other Names:
  • SKYRIZI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Experiencing Adverse Events (AEs)
Time Frame: Up to approximately 140 days
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study.
Up to approximately 140 days
Maximum Observed Serum Concentration (Cmax)
Time Frame: Up to approximately 113 days
Maximum observed serum concentration (Cmax) of risankizumab.
Up to approximately 113 days
Time to Cmax (Tmax)
Time Frame: Up to approximately 113 days
Time to Cmax of risankizumab.
Up to approximately 113 days
Apparent Terminal Phase Elimination Rate Constant (β)
Time Frame: Up to approximately 113 days
Apparent terminal phase elimination rate constant (β) of risankizumab.
Up to approximately 113 days
Terminal Phase Elimination Hhalf-life (t1/2)
Time Frame: Up to approximately 113 days
Terminal phase elimination half-life (t1/2) of risankizumab.
Up to approximately 113 days
Area Under Concentration-Time Curve (AUC) From Time 0 to Time of the Last Measurable Concentration (AUCt)
Time Frame: Up to approximately 113 days
AUCt of risankizumab.
Up to approximately 113 days
AUC From Time 0 to Infinity (AUCinf)
Time Frame: Up to approximately 113 days
AUCinf of risankizumab.
Up to approximately 113 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2020

Primary Completion (ACTUAL)

July 6, 2021

Study Completion (ACTUAL)

July 6, 2021

Study Registration Dates

First Submitted

March 8, 2022

First Submitted That Met QC Criteria

March 8, 2022

First Posted (ACTUAL)

March 10, 2022

Study Record Updates

Last Update Posted (ACTUAL)

March 10, 2022

Last Update Submitted That Met QC Criteria

March 8, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M19-128

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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