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

NCT03536325 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2019-01-23

No results posted yet for this study

Summary

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.

Conditions

  • Healthy

Interventions

DRUG

Guselkumab Dose 1

Participants will receive Dose 1 of guselkumab on Day 1.

DRUG

Guselkumab Dose 2

Participants will receive Dose 2 of guselkumab on Day 1.

DRUG

Guselkumab Dose 3

Participants will receive Dose 3 of guselkumab on Day 1.

DRUG

Placebo

Participants will receive matching placebo on Day 1.

Sponsors & Collaborators

  • Janssen Pharmaceutical K.K.

    lead INDUSTRY

Principal Investigators

  • Janssen Pharmaceutical K.K., Japan Clinical Trial · Janssen Pharmaceutical K.K.

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-05-31
Primary Completion
2018-10-25
Completion
2018-10-25

Countries

  • Japan

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03536325 on ClinicalTrials.gov