NCT02291991

Study to Evaluate Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of GX-E2 in Healthy Subjects

A Randomized, Double-blind Placebo Controlled, Single-dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of GX-E2 After Single Intravenous Administration in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Genexine, Inc. · Industry
• Sex: Male
• Age: 20 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a randomized, placebo controlled, single dose study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of GX-E2 in healthy male subjects.

Detailed description

The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of GX-E2 when given as single dose (GX-E2 8 ug/kg) to healthy male subjects. Additionally, Immunogenecity will be evaluated to investigate antibody production.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	GX-E2	Investigational drug(GX-E2 or Placebo) will be administered to healthy volunteers by the intravenous route.
DRUG	GX-E2	Investigational drug(GX-E2 or Placebo) will be administered to healthy volunteers by the intravenous route.

Timeline

• Start date: 2014-11-01
• Primary completion: 2015-01-01
• Completion: 2015-01-01
• First posted: 2014-11-17
• Last updated: 2015-01-29

Locations

1 site across 1 country: South Korea