NCT04030533

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

A Study to Evaluate the Pharmacokinetics of Guselkumab and Ustekinumab Following a Single Intravenous or Subcutaneous Administration in Healthy Chinese Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2019-11-29
• Primary completion: 2020-12-31
• Completion: 2020-12-31
• First posted: 2019-07-24
• Last updated: 2025-02-03

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study