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

NCT04030533 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-02-03

No results posted yet for this study

Summary

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.

Conditions

  • Healthy

Interventions

DRUG

Guselkumab (SC): Dose 1

Participants will receive a single dose of guselkumab (dose 1) subcutaneously.

DRUG

Guselkumab (SC): Dose 2

Participants will receive a single dose of guselkumab (dose 2) subcutaneously.

DRUG

Guselkumab (IV): Dose 1

Participants will receive a single IV infusion of guselkumab (dose 1).

DRUG

Guselkumab (IV): Dose 2

Participants will receive a single IV infusion of guselkumab (dose 2).

DRUG

Ustekinumab 6 mg/mL

Participants will receive a single IV infusion of ustekinumab 6 mg/mL solution.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-11-29
Primary Completion
2020-12-31
Completion
2020-12-31
FDA Drug
Yes

Countries

  • China

Study Locations

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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 NCT04030533 on ClinicalTrials.gov