NCT03014895

A Single Intravenous Dose Study of E3112 in Japanese Healthy Adult Male Subjects

A Randomized, Double-blind, Placebo-controlled, Single Intravenous Ascending Dose Study of E3112 in Japanese Healthy Adult Male Subjects

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: EA Pharma Co., Ltd. · Industry
• Sex: Male
• Age: 20 Years – 44 Years
• Healthy volunteers: Accepted

Summary

The study (E3112/CP1) is a single-center, randomized, double-blind, placebo-controlled, single intravenous ascending dose study conducted in Japanese healthy adult males to evaluate the pharmacokinetics (PK), safety, and immunogenicity of E3112 following a single intravenous dose of E3112.

Conditions

• Healthy Male Volunteers

Interventions

Type	Name	Description
DRUG	Placebo	Intravenous infusion
DRUG	E3112	Intravenous infusion

Timeline

• Start date: 2017-01-25
• Primary completion: 2017-06-12
• Completion: 2017-11-22
• First posted: 2017-01-09
• Last updated: 2018-11-14

Locations

1 site across 1 country: Japan