A Study to Evaluate the Bioavailability of Risankizumab in Pre-filled Syringe or Auto-injector in Healthy Adult Participants

Part of paid clinical trials in Grayslake, Illinois.

Sponsor
AbbVie
Study ID
NCT05283681
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Volunteers

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Risankizumab — DRUG
    Subcutaneous Injection via Prefilled Syringe (PFS)
  • Risankizumab — DRUG
    Subcutaneous Injection via Auto-Injector (AI)

Study Details

The objective of this study is to evaluate the bioavailability of risankizumab new formulation in prefilled syringe (PFS) relative to the 90 mg/mL formulation in PFS in healthy volunteers. The study will also evaluate the bioavailability of risankizumab new formulation in auto-injector (AI) relative to PFS in healthy volunteers.

Key Dates

Start date
Apr 2, 2019
Status verified
Mar 2022
Primary completion
Nov 11, 2019
Completion
Nov 11, 2019

Study Design

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

Arms

  • Experimental: Risankizumab Dose A
    Participants will receive 1 Subcutaneous (SC) injection of risankizumab Dose A administered via Prefilled Syringe (PFS) at Day 1 and followed for 140 days
  • Experimental: Risankizumab Dose B
    Participants will receive SC injections of risankizumab Dose B administered via PFS at Day 1 and followed for 140 days
  • Experimental: Risankizumab Dose C
    Participants will receive 1 SC injection of risankizumab Dose C administered via Auto-Injector (AI) at Day 1 and followed for 140 days.

Primary Outcome Measure

Number of Participants with Adverse Events [ Time Frame: Up to 140 Days ]

Locations (2)

FacilityCityStateZIPSite coordinators
Acpru /Id# 210844GrayslakeIllinois60030-
PPD Clinical Research Unit - Austin /ID# 211456AustinTexas78744-

Find similar trials in Grayslake, IL

By research site
Acpru· Grayslake, ILPPD Clinical Research Unit - Austin· Austin, TX

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