A Study to Assess the Bioequivalence of Ustekinumab by Two Different Injection Devices in Healthy Participants

Part of paid clinical trials in Tempe, Arizona.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT04816513
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Ustekinumab — DRUG
    Ustekinumab will be administered as SC injection.

Study Details

The purpose of this study is to evaluate the pharmacokinetic (PK) and bioequivalence (BE) of ustekinumab administered by a single subcutaneous (SC) injection with Device 1 or Device 2 in healthy participants.

Key Dates

Start date
Apr 14, 2021
Status verified
Apr 2025
Primary completion
Jan 7, 2022
Completion
Jan 26, 2022

Study Design

Enrollment
300 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Active Comparator: Ustekinumab (Using Reference Device)
    Participants will receive a single subcutaneous (SC) injection of ustekinumab in Device 1 as a reference device on Day 1.
  • Experimental: Ustekinumab (Using Test Device)
    Participants will receive a single SC injection of ustekinumab in Device 2 as a test device on Day 1.

Primary Outcome Measure

Maximum Observed Serum Concentrations (Cmax) of Ustekinumab [ Time Frame: Up to Day 85 ]

Locations (3)

FacilityCityStateZIPSite coordinators
CelerionTempeArizona85283-
CelerionLincolnNebraska68502-
PRA Health SciencesSalt Lake CityUtah84124-

Find similar trials in Tempe, AZ

By research site
Celerion· Tempe, AZCelerion· Lincoln, NEPRA Health Sciences· Salt Lake City, UT

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