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Study of Intravenous and Subcutaneous Administration of Risankizumab in Healthy Participants

Sponsor
AbbVie (Industry)
Overall Status
Completed
CT.gov ID
NCT05274100
Collaborator
(none)
394
Enrollment
8
Locations
5
Arms
10.1
Actual Duration (Months)
49.3
Patients Per Site
4.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).
Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
394 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
A Phase 1, Pharmacokinetic Comparability Study of Intravenous and Subcutaneous Administration of Risankizumab in Healthy Subjects
Actual Study Start Date :
Sep 1, 2020
Actual Primary Completion Date :
Jul 6, 2021
Actual Study Completion Date :
Jul 6, 2021

Arms and Interventions

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

    		•
    Experimental: Group 2: Risankizumab Dose B

    Participants will receive risankizumab dose B.

    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 on-body delivery system (OBDS)
    Other Names:
  • SKYRIZI

    		•
    Experimental: Group 4: Risankizumab Dose D

    Participants will receive risankizumab dose D.

    Drug: Risankizumab
    Intravenous Infusion
    Other Names:
  • SKYRIZI

    		•
    Experimental: Group 5: Risankizumab Dose D

    Participants will receive risankizumab dose D.

    Drug: Risankizumab
    Intravenous Infusion
    Other Names:
  • SKYRIZI

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of Participants Experiencing Adverse Events (AEs) [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.

    2. Maximum Observed Serum Concentration (Cmax) [Up to approximately 113 days]

      Maximum observed serum concentration (Cmax) of risankizumab.

    3. Time to Cmax (Tmax) [Up to approximately 113 days]

      Time to Cmax of risankizumab.

    4. Apparent Terminal Phase Elimination Rate Constant (β) [Up to approximately 113 days]

      Apparent terminal phase elimination rate constant (β) of risankizumab.

    5. Terminal Phase Elimination Hhalf-life (t1/2) [Up to approximately 113 days]

      Terminal phase elimination half-life (t1/2) of risankizumab.

    6. Area Under Concentration-Time Curve (AUC) From Time 0 to Time of the Last Measurable Concentration (AUCt) [Up to approximately 113 days]

      AUCt of risankizumab.

    7. AUC From Time 0 to Infinity (AUCinf) [Up to approximately 113 days]

      AUCinf of risankizumab.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Anaheim Clinical Trials LLC /ID# 222821 Anaheim California United States 92801-2658
    2 Altasciences Clinical Los Angeles, Inc /ID# 222238 Cypress California United States 90630
    3 Clinical Pharmacology of Miami /ID# 225392 Miami Florida United States 33014
    4 PPD Clinical Research Unit /ID# 222362 Orlando Florida United States 32806-1044
    5 Acpru /Id# 222349 Grayslake Illinois United States 60030
    6 PPD Clinical Research Unit -Las Vegas /ID# 222363 Las Vegas Nevada United States 89113-2235
    7 PPD Clinical Research Unit - Austin /ID# 222361 Austin Texas United States 78744
    8 Spaulding Clinical Research LLC /ID# 225405 West Bend Wisconsin United States 53095

    Sponsors and Collaborators

    • AbbVie

    Investigators

    • Study Director: ABBVIE INC., AbbVie

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    AbbVie
    ClinicalTrials.gov Identifier:
    NCT05274100
    Other Study ID Numbers:
    • M19-128
    First Posted:
    Mar 10, 2022
    Last Update Posted:
    Mar 10, 2022
    Last Verified:
    Mar 1, 2022
    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
    Keywords provided by AbbVie
    Risankizumab
    SKYRIZI
    Additional relevant MeSH terms:
    Antibodies, Monoclonal

    Study Results

    No Results Posted as of Mar 10, 2022