NCT01606163

Safety and Pharmacokinetics Study of Healthy Male Adults When Repeatedly Administered Through Intravenous Injection

A Phase 1, Randomized, Double-blind, Placebo-controlled, Multiple-dose, Dose Escalation Study to Assess the Safety and Pharmacokinetics of GC1102 (Hepabig-Gene) in Healthy Male Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Green Cross Corporation · Industry
• Sex: Male
• Age: 20 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety and pharmacokinetics of healthy male adults when subjects are repeatedly administered GC1102 (Hepabig\_Gene) through intravenous injection.

Conditions

• Hepatitis B

Interventions

Type	Name	Description
BIOLOGICAL	GC1102	1. Description: GC1102 IV bolus injection during 10\~ 30 seconds. 2. Amount: group1-3ml, group2-5ml, group3-8ml 3. Subject number: group1-8, group2-8, group3-8 4. Administration time: 1day, 2day, 3day, 4day, 5day, 6day, 7day(total: 7 times)
OTHER	JW normal saline	1. Description: Normal saline IV bolus injection through 10\~ 30 seconds. * Each 3 subjects of this placebo comparator group will match with group 1,2,3 respectively. Placebo comparator subjects in each group will be treated with same condition of each group(group 1, group 2, group 3) except being administered JW normal saline. 2. Subject number: 9 3. Administration time: 1day, 2day, 3day, 4day, 5day, 6day, 7day(total: 7 times)

Timeline

• Start date: 2012-08-01
• Primary completion: 2013-06-01
• Completion: 2013-12-01
• First posted: 2012-05-25
• Last updated: 2014-01-03

Locations

1 site across 1 country: South Korea