Trials / Completed
CompletedNCT03536325
A Study to Assess the Safety, Tolerability and Pharmacokinetics of Guselkumab Following a Single Intravenous Administration in Healthy Japanese Participants
A Double-blind, Placebo-controlled, Randomized, Single Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of Guselkumab Following a Single Intravenous Administration in Healthy Japanese Subjects
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 24 (actual)
- Sponsor
- Janssen Pharmaceutical K.K. · Industry
- Sex
- Male
- Age
- 20 Years – 55 Years
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2018-05-31
- Primary completion
- 2018-10-25
- Completion
- 2018-10-25
- First posted
- 2018-05-24
- Last updated
- 2019-01-23
Locations
1 site across 1 country: Japan
Source: ClinicalTrials.gov record NCT03536325. Inclusion in this directory is not an endorsement.