Study of Guselkumab and Ustekinumab Following a Single Intravenous or Subcutaneous Administration in Healthy Chinese Participants

Sponsor
Janssen Research & Development, LLC
Study ID
NCT04030533
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

Study Details

The purpose of this study is to evaluate the pharmacokinetics (PK) of guselkumab following a single intravenous (IV) or subcutaneous (SC) administration in healthy Chinese participants; to evaluate the PK of ustekinumab following a single IV administration in healthy participants.

Key Dates

Start date
Nov 29, 2019
Status verified
Jan 2025
Primary completion
Dec 31, 2020
Completion
Dec 31, 2020

Study Design

Enrollment
60 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER

Arms

  • Experimental: Cohort 1: Guselkumab (SC): Dose 1
    Participants will receive a single subcutaneous (SC) injection of guselkumab (dose 1), administered on Day 1.
  • Experimental: Cohort 2: Guselkumab (SC): Dose 2
    Participants will receive a single SC injection of guselkumab (dose 2), administered on Day 1.
  • Experimental: Cohort 3: Guselkumab (IV): Dose 1
    Participants will receive a single intravenous (IV) infusion of guselkumab (dose 1), administered on Day 1.
  • Experimental: Cohort 4: Guselkumab (IV): Dose 2
    Participants will receive a single IV infusion of guselkumab (dose 2), administered on Day 1.
  • Experimental: Cohort 5: Ustekinumab (IV): 6 mg/mL
    Participants will receive a single IV infusion of ustekinumab 6 milligrams per milliliter (mg/mL) solution on Day 1.

Primary Outcome Measure

Maximum Observed Serum Concentration (Cmax) [ Time Frame: Predose (Day 1), 1, 4, 12, 24, 48, 72, 96, 120, and 144 hours postdose (Day 7); Days 15, 22, 29, 43, 57, 71, and 85 ]

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