Study of Intravenous and Subcutaneous Administration of Risankizumab in Healthy Participants

Part of paid clinical trials in Anaheim, California.

Sponsor
AbbVie
Study ID
NCT05274100
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Volunteers

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

  • Risankizumab — DRUG
    Subcutaneous Injection via prefilled syringe (PFS)
  • Risankizumab — DRUG
    Intravenous Infusion
  • Risankizumab — DRUG
    Subcutaneous Injection via on-body delivery system (OBDS)

Study Details

The primary objectives of this study are to assess the relative bioavailability of risankizumab in on-body delivery system (OBDS) versus the prefilled syringe (PFS) (Substudy 1) and to assess the relative bioavailability of risankizumab in the to-be-marketed Dose A liquid vial versus the Dose B liquid vial used in the Phase 3 studies (Substudy 2).

Key Dates

Start date
Sep 1, 2020
Status verified
Mar 2022
Primary completion
Jul 6, 2021
Completion
Jul 6, 2021

Study Design

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

Arms

  • Experimental: Group 1: Risankizumab Dose A
    Participants will receive risankizumab dose A.
  • Experimental: Group 2: Risankizumab Dose B
    Participants will receive risankizumab dose B.
  • Experimental: Group 3: Risankizumab Dose C
    Participants will receive risankizumab dose C.
  • Experimental: Group 4: Risankizumab Dose D
    Participants will receive risankizumab dose D.
  • Experimental: Group 5: Risankizumab Dose D
    Participants will receive risankizumab dose D.

Primary Outcome Measure

Percentage of Participants Experiencing Adverse Events (AEs) [ Time Frame: Up to approximately 140 days ]

Locations (8)

FacilityCityStateZIPSite coordinators
Anaheim Clinical Trials LLC /ID# 222821AnaheimCalifornia92801-2658-
Altasciences Clinical Los Angeles, Inc /ID# 222238CypressCalifornia90630-
Clinical Pharmacology of Miami /ID# 225392MiamiFlorida33014-
PPD Clinical Research Unit /ID# 222362OrlandoFlorida32806-1044-
Acpru /Id# 222349GrayslakeIllinois60030-
PPD Clinical Research Unit -Las Vegas /ID# 222363Las VegasNevada89113-2235-
PPD Clinical Research Unit - Austin /ID# 222361AustinTexas78744-
Spaulding Clinical Research LLC /ID# 225405West BendWisconsin53095-

Find similar trials in Anaheim, CA

By research site
Anaheim Clinical Trials LLC· Anaheim, CAAltasciences Clinical Los Angeles, Inc· Cypress, CAClinical Pharmacology of Miami· Miami, FLPPD Clinical Research Unit· Orlando, FLAcpru· Grayslake, ILPPD Clinical Research Unit -Las Vegas· Las Vegas, NV

Related Studies