A Study to Assess Pharmacokinetic Exposures Following Intravenous and Subcutaneous Administration of Risankizumab in Healthy Participants

Part of paid clinical trials in Miami, Florida.

Sponsor
AbbVie
Study ID
NCT06487572
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Volunteers

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

Study Details

The objective of this study is to compare pharmacokinetic exposures following intravenous and subcutaneous administration of Risankizumab.

Key Dates

Start date
Jul 23, 2024
Status verified
Feb 2025
Primary completion
Feb 7, 2025
Completion
Feb 7, 2025

Study Design

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

Arms

  • Experimental: Risankizumab Dose A for Intravenous (IV) Infusion
    Participants will receive IV infusion of risankizumab at dose A and then followed for 140 days.
  • Experimental: Risankizumab Dose B for Subcutaneous (SC) Injection
    Participants will receive SC injections of risankizumab at dose B and then followed for 140 days.

Primary Outcome Measure

Number of Participants Experiencing Adverse Events [ Time Frame: Up to approximately 140 days ]

Locations (2)

FacilityCityStateZIPSite coordinators
Clinical Pharmacology Of Miami /ID# 268219MiamiFlorida33014-
Acpru /Id# 267057GrayslakeIllinois60030-

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