NCT03689153

A Study of JNJ-63733657 in Healthy Japanese Participants

A Randomized, Placebo-controlled, Double-blind, Single Ascending Dose Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-63733657 in Healthy Japanese Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Janssen Pharmaceutical K.K. · Industry
• Sex: All
• Age: 55 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the safety and tolerability of JNJ-63733657 following single ascending intravenous (IV) dose administration in healthy Japanese participants.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	JNJ-63733657	Single ascending IV low, middle, and high dose of JNJ-63733657 will be administered in sequential cohorts. The progression to the next (higher) dose level is dependent on acceptable safety and tolerability profile of JNJ-63733657 obtained after dose administration of the current dose level. The length of time between dosing days of cohorts will be at least 14 days.
DRUG	Placebo	Participants will receive matching placebo intravenously.

Timeline

• Start date: 2018-09-28
• Primary completion: 2019-07-11
• Completion: 2019-07-11
• First posted: 2018-09-28
• Last updated: 2025-04-28

Locations

1 site across 1 country: Japan