NCT03618160

A Study to Assess the Safety, Tolerability and Pharmacokinetics of Subcutaneous (SC) Injections of JNJ-64565111 in Healthy Male Japanese Participants and to Assess Pharmacokinetics Following Subcutaneous Injections of JNJ-64565111 in Healthy Male Caucasian Participants

A Double-blind, Placebo-controlled, Randomized, Single Ascending Dose and Multiple Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics Following Subcutaneous Injections of JNJ-64565111 in Healthy Male Japanese Subjects and An Open-label, Single Dose Study to Assess Pharmacokinetics Following Subcutaneous Injections of JNJ-64565111 in Healthy Male Caucasian Subjects

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Janssen Pharmaceutical K.K. · Industry
• Sex: Male
• Age: 20 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the safety, tolerability, and pharmacokinetics (PK) of JNJ-64565111 following single and multiple subcutaneous (SC) doses in healthy Japanese male participants.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	JNJ-64565111	Participants in Cohorts 1 to 3 will receive a single SC low, medium, and high dose of JNJ-64565111 respectively on Day 1, participants in Cohorts 4 to 6 will receive weekly multiple SC low, high and medium dose of JNJ-64565111 respectively on Days 1, 8, 15, and 22, under fasted conditions. Participants in Cohort 7 will receive a single SC medium dose of JNJ-64565111 on Day 1, under fasted conditions.
DRUG	Placebo	Participants will receive SC injection of matching placebo on Day 1 in all cohorts of Part 1 and on Days 1, 8, 15, and 22 in Part 2 under fasted conditions.

Timeline

• Start date: 2018-08-06
• Primary completion: 2019-06-21
• Completion: 2019-06-21
• First posted: 2018-08-07
• Last updated: 2025-02-03

Locations

2 sites across 1 country: Japan