NCT03080987

A Study to Assess the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of JNJ-64179375 in Healthy Japanese Participants

A 2-Part Study to Assess the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of JNJ-64179375 in Healthy Japanese Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 20 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The primary purpose of this study is to assess the safety and tolerability of JNJ-64179375 in Part 1 and 2.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	JNJ-64179375 0.3 mg/kg	JNJ-64179375 0.3 milligram per kilogram (mg/kg) intravenous (IV) infusion on Day 1.
DRUG	JNJ-64179375 1.0 mg/kg	JNJ-64179375 1.0 mg/kg on Day 1 administered as IV infusion (for Part 1) and SC injection (for Part 2).
DRUG	JNJ-64179375 2.5 mg/kg	JNJ-64179375 2.5 mg/kg IV infusion on Day 1.
OTHER	Placebo	Matching placebo on Day 1 administered as IV infusion (for Part 1) and SC injection (for Part 2).
DRUG	JNJ-64179375 (Dose to be Determined)	JNJ-64179375 IV infusion (Dose to be determined).

Timeline

• Start date: 2017-06-27
• Primary completion: 2018-06-25
• Completion: 2018-06-25
• First posted: 2017-03-15
• Last updated: 2025-02-03

Locations

2 sites across 2 countries: Japan, United Kingdom