We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study to Evaluate the Relative Bioavailability of Two Risankizumab Drug Product Presentations in Healthy Volunteers.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05567029
Recruitment Status : Active, not recruiting
First Posted : October 5, 2022
Last Update Posted : January 13, 2023
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief Summary:

This study will assess how safe risankizumab is and how risankizumab moves through the body of adult healthy participants. Adverse Events will be assessed.

Risankizumab is an investigational drug being developed for the treatment of Crohn's Disease. Participants are randomly assigned to one of the 2 treatment groups. Approximately 198 adult healthy volunteers will be enrolled in at least 4 sites across the world.

All participants will receive risankizumab as subcutaneous injections in one of the 2 different formulations.

There may be higher burden for participants in this trial. Participants will be confined for 10 days and followed up for 140 days. Adverse Events and blood tests will be collected.


Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: Risankizumab Dose A Drug: Risankizumab Dose B Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 198 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Phase 1 Study in Healthy Subjects to Evaluate the Bioavailability of Risankizumab 150mg/mL Formulation in the 180 mg Prefilled Syringe Relative to 90mg/mL Formulation in the 90 mg Prefilled Syringe
Actual Study Start Date : September 28, 2022
Estimated Primary Completion Date : May 6, 2023
Estimated Study Completion Date : May 6, 2023

Arm Intervention/treatment
Experimental: Risankizumab Dose A
Participants will receive subcutaneous dose of risankizumab dose A.
Drug: Risankizumab Dose A
Prefilled Syringe

Experimental: Risankizumab Dose B
Participants will receive subcutaneous dose of risankizumab dose B.
Drug: Risankizumab Dose B
Prefilled Syringe




Primary Outcome Measures :
  1. Maximum Observed Plasma Concentration (Cmax) [ Time Frame: Approximately up to 113 days ]
    Maximum Observed Plasma Concentration (Cmax)

  2. Time to Maximum Observed Plasma Concentration (Tmax) [ Time Frame: Approximately up to 113 days ]
    Time to Maximum Observed Plasma Concentration (Tmax)

  3. Apparent Terminal Phase Elimination Rate Constant (β) [ Time Frame: Approximately up to 113 days ]
    Apparent Terminal Phase Elimination Rate Constant (β)

  4. The Terminal Phase Elimination Half-Life (t1/2) [ Time Frame: Approximately up to 113 days ]
    The Terminal Phase Elimination Half-Life (t1/2)

  5. The Area Under the Plasma Concentration-Time Curve (AUC) from Time 0 to Time of the Last Measurable Concentration (AUCt) [ Time Frame: Approximately up to 113 days ]
    The Area Under the Plasma Concentration-Time Curve (AUC) from Time 0 to Time of the Last Measurable Concentration (AUCt)

  6. The Area Under the Plasma Concentration-Time Curve (AUC) from Time 0 to Infinity (AUC∞) [ Time Frame: Approximately up to 113 days ]
    The Area Under the Plasma Concentration-Time Curve (AUC) from Time 0 to Infinity (AUC∞)

  7. Number of Participants with Adverse Events [ Time Frame: Approximately up to 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

- Body weight greater than 40 kg and less than 100 kg at screening and upon initial confinement.

Exclusion Criteria:

  • Previous exposure to any anti-interleukin-12/23 or anti-interleukin-23 treatment.
  • Intention to perform strenuous exercise to which the participant is unaccustomed within one week prior to administration of study drug or during the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05567029


Locations
Layout table for location information
United States, California
Anaheim Clinical Trials LLC /ID# 250098
Anaheim, California, United States, 92801-2658
United States, Florida
Clinical Pharmacology of Miami /ID# 250099
Miami, Florida, United States, 33014
United States, Illinois
Acpru /Id# 249681
Grayslake, Illinois, United States, 60030
United States, Missouri
Bio-Kinetic Clinical Applications, LLC /ID# 250181
Springfield, Missouri, United States, 65802-4842
United States, Texas
PPD Clinical Research Unit - Austin /ID# 250672
Austin, Texas, United States, 78744
Sponsors and Collaborators
AbbVie
Investigators
Layout table for investigator information
Study Director: ABBVIE INC. AbbVie
Layout table for additonal information
Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT05567029    
Other Study ID Numbers: M23-522
First Posted: October 5, 2022    Key Record Dates
Last Update Posted: January 13, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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
Additional relevant MeSH terms:
Layout table for MeSH terms
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs