A Study to Assess the Relative Bioavailability of Risankizumab Following Subcutaneous Administrations With a Pre-Filled Syringe or an On-Body Injector in Healthy Adult Participants

Part of paid clinical trials in Miami, Florida.

Sponsor
AbbVie
Study ID
NCT07007091
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 the pharmacokinetics and relative Bioavailability of risankizumab following subcutaneous administration with an on-body injector relative to a prefilled syringe

Key Dates

Start date
Jun 12, 2025
Status verified
Jan 2026
Primary completion
Jan 15, 2026
Completion
Jan 15, 2026

Study Design

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

Arms

  • Experimental: Arm 1: Risankizumab Prefilled Syringe (PFS)
    Participants will receive a Subcutaneous (SC) single dose of Risankizumab PFS on Day 1
  • Experimental: Arm 2: Risankizumab On-Body Injector (OBI)
    Participants will receive a Subcutaneous (SC) single dose of Risankizumab OBI on Day 1

Primary Outcome Measure

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

Locations (4)

FacilityCityStateZIPSite coordinators
Cpmi /Id# 276490MiamiFlorida33172-
Acpru /Id# 276043GrayslakeIllinois60030-
Ppd - Las Vegas Research Unit /ID# 276565Las VegasNevada89113-
PPD Phase I Clinic /ID# 276525AustinTexas78744-

Find similar trials in Miami, FL

By research site
Cpmi· Miami, FLAcpru· Grayslake, ILPpd - Las Vegas Research Unit· Las Vegas, NVPPD Phase I Clinic· Austin, TX

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