A Study to Assess the Bioavailability of Risankizumab Following Subcutaneous Administration With Prefilled Pen Relative to a Prefilled Syringe in Healthy Adult Participants

Part of paid clinical trials in Cypress, California.

Sponsor
AbbVie
Study ID
NCT06946524
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, relative bioavailability, immunogenicity, safety, and tolerability of risankizumab following subcutaneous (SC) administration with a prefilled pen or a prefilled syringe in healthy adult participants.

Key Dates

Start date
May 8, 2025
Status verified
Dec 2025
Primary completion
Nov 25, 2025
Completion
Nov 25, 2025

Study Design

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

Arms

  • Experimental: Risankizumab Arm A
    Participants will receive a single Subcutaneous (SC) injection of risankizumab Dose A administered via Prefilled Syringe (PFS) at Day 1
  • Experimental: Risankizumab Arm B
    Participants will receive a single Subcutaneous (SC) injection of risankizumab Dose B administered via Prefilled Pen (PFP) at Day 1

Primary Outcome Measure

Maximum Observed Plasma Concentration (Cmax) of Risankizumab [ Time Frame: Up to approximately 141 days ]

Locations (2)

FacilityCityStateZIPSite coordinators
Altasciences Clinical Los Angeles /ID# 276446CypressCalifornia90630-
Acpru /Id# 275116GrayslakeIllinois60030-

Find similar trials in Cypress, CA

By research site
Altasciences Clinical Los Angeles· Cypress, CAAcpru· Grayslake, IL

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