NCT01951027

Phase I Study GX-G3 in Healthy Subjects

A Dose-block Randomized, Double-blind, Placebo-controlled, Dose-escalation Phase I Study to Investigate the Safety, Tolerability, and PK/PD of GX-G3 After Single SC Administration in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Genexine, Inc. · Industry
• Sex: Male
• Age: 20 Years – 45 Years
• Healthy volunteers: Accepted

Summary

pharmacokinetics/pharmacodynamics of GX-G3 after single subcutaneous administration in healthy male subjects.

Detailed description

MTD will be determined by DLT occurrence and frequency, and severity and charactoristic of adverse event, vital sign, physical examination, ECG, Laboratory test, chest-X-ray will be examined for safety evaluation. The second purpose is to evaluate pharmacokinetics and pharmacodynamics, and immunogenecity will be evaluated to investigate antibody production.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	GX-G3 12.5 μg/kg or Placebo	Single SC injection
DRUG	GX-G3 25 μg/kg or Placebo	Single SC injection
DRUG	GX-G3 50 μg/kg or Placebo	Single SC injection
DRUG	GX-G3 100 μg/kg or Placebo	Single SC injection

Timeline

• Start date: 2013-09-01
• Primary completion: 2014-07-01
• Completion: 2014-12-01
• First posted: 2013-09-26
• Last updated: 2015-01-29

Locations

1 site across 1 country: South Korea