A Study to Assess the Safety, Tolerability and Pharmacokinetics of Guselkumab Following a Single Intravenous Administration in Healthy Japanese Participants

Sponsor
Janssen Pharmaceutical K.K.
Study ID
NCT03536325
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
MALE
Age
20 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Guselkumab Dose 1 — DRUG
    Participants will receive Dose 1 of guselkumab on Day 1.
  • Guselkumab Dose 2 — DRUG
    Participants will receive Dose 2 of guselkumab on Day 1.
  • Guselkumab Dose 3 — DRUG
    Participants will receive Dose 3 of guselkumab on Day 1.
  • Placebo — DRUG
    Participants will receive matching placebo on Day 1.

Study Details

The purpose of this study is to assess the safety and tolerability of guselkumab following single-dose intravenous (IV) infusion in Japanese healthy male participants.

Key Dates

Start date
May 31, 2018
Status verified
Jan 2019
Primary completion
Oct 25, 2018
Completion
Oct 25, 2018

Study Design

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

Arms

  • Experimental: Cohort 1: Guselkumab Dose 1 or Placebo
    Participants will receive Dose 1 of guselkumab or matching placebo as an intravenous (IV) infusion on Day 1.
  • Experimental: Cohort 2: Guselkumab Dose 2 or Placebo
    Participants will receive Dose 2 of guselkumab or matching placebo as an IV infusion on Day 1.
  • Experimental: Cohort 3: Guselkumab Dose 3 or Placebo
    Participants will receive Dose 3 of guselkumab or matching placebo as an IV infusion on Day 1 based on safety data results received from Cohort 1 and 2.

Primary Outcome Measure

Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability [ Time Frame: Up to approximately 20 weeks ]

Related Studies