A Study to Assess the Relative Bioavailability of Two Formulations of Risankizumab Following Subcutaneous Administration With Prefilled Syringes in Healthy Adult Participants

Part of paid clinical trials in Anaheim, California.

Sponsor
AbbVie
Study ID
NCT06571266
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Volunteers

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

  • Risankizumab — DRUG
    • Subcutaneous Injection via prefilled syringe

Study Details

This study will assess the pharmacokinetics, relative bioavailability and tolerability of two formulations of risankizumab following subcutaneous (SC) administration in healthy adult participants.

Key Dates

Start date
Sep 11, 2024
Status verified
May 2025
Primary completion
Apr 16, 2025
Completion
Apr 16, 2025

Study Design

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

Arms

  • Experimental: Risankizumab Formulation 1
    Participants will receive a single dose of Risankizumab formulation 1 on day 1.
  • Experimental: Risankizumab Formulation 2
    Participants will receive a single dose of Risankizumab formulation 2 on day 1.
  • Experimental: Risankizumab Formulation 3
    Participants will receive a single dose of Risankizumab formulation 3 on day 1.

Primary Outcome Measure

Number of Participants with Adverse Events (AEs) [ Time Frame: Up to day 140 ]

Locations (3)

FacilityCityStateZIPSite coordinators
Cenexel Act /ID# 270310AnaheimCalifornia92801-
Collaborative Neuroscience Research CNS /ID# 270286Los AlamitosCalifornia90720-
Acpru /Id# 270152GrayslakeIllinois60030-

Find similar trials in Anaheim, CA

By research site
Cenexel Act· Anaheim, CACollaborative Neuroscience Research CNS· Los Alamitos, CAAcpru· Grayslake, IL

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