A Study to Assess the Relative Bioavailability of Risankizumab Following Subcutaneous Administration With On-Body Injector in Healthy Adult Participants

Part of paid clinical trials in Anaheim, California.

Sponsor
AbbVie
Study ID
NCT06937619
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Volunteer

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

Study Details

This study will assess the pharmacokinetics and relative Bioavailability of risankizumab following subcutaneous (SC) administration with on-body Injector in Healthy Adult Participants.

Key Dates

Start date
Apr 21, 2025
Status verified
Nov 2025
Primary completion
Nov 10, 2025
Completion
Nov 10, 2025

Study Design

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

Arms

  • Experimental: Risankizumab Arm A
    Participants will receive a single dose of Risankizumab On-Body Injector (OBI) produced by new process on Day 1.
  • Experimental: Risankizumab Arm B
    Participants will receive a single dose of Risankizumab On-Body Injector (OBI) produced by current process on Day 1.

Primary Outcome Measure

Maximum Observed Plasma Concentration (Cmax) of Risankizumab [ Time Frame: Up to approximately 140 days ]

Locations (4)

FacilityCityStateZIPSite coordinators
CenExel ACT- Anaheim Clinical Trials /ID# 274805AnaheimCalifornia92801-
Collaborative Neuroscience Research CNS /ID# 275212Los AlamitosCalifornia90720-
Cpmi /Id# 274464MiamiFlorida33172-
Acpru /Id# 271954GrayslakeIllinois60030-

Find similar trials in Anaheim, CA

By research site
CenExel ACT- Anaheim Clinical Trials· Anaheim, CACollaborative Neuroscience Research CNS· Los Alamitos, CACpmi· Miami, FLAcpru· Grayslake, IL

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