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

Part of paid clinical trials in Anaheim, California.

Sponsor
AbbVie
Study ID
NCT05567029
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Volunteers

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

Study Details

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.

Key Dates

Start date
Sep 28, 2022
Status verified
Apr 2023
Primary completion
Apr 20, 2023
Completion
Apr 20, 2023

Study Design

Enrollment
198 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Risankizumab Dose A
    Participants will receive subcutaneous dose of risankizumab dose A.
  • Experimental: Risankizumab Dose B
    Participants will receive subcutaneous dose of risankizumab dose B.

Primary Outcome Measure

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

Locations (5)

FacilityCityStateZIPSite coordinators
Anaheim Clinical Trials LLC /ID# 250098AnaheimCalifornia92801-2658-
Clinical Pharmacology of Miami /ID# 250099MiamiFlorida33014-
Acpru /Id# 249681GrayslakeIllinois60030-
Bio-Kinetic Clinical Applications, LLC /ID# 250181SpringfieldMissouri65802-
PPD Clinical Research Unit - Austin /ID# 250672AustinTexas78744-

Find similar trials in Anaheim, CA

By research site
Anaheim Clinical Trials LLC· Anaheim, CAClinical Pharmacology of Miami· Miami, FLAcpru· Grayslake, ILBio-Kinetic Clinical Applications, LLC· Springfield, MOPPD Clinical Research Unit - Austin· Austin, TX

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