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

PHASE1CompletedINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

August 31, 2012

Primary Completion Date

June 30, 2013

Study Completion Date

December 31, 2013

Conditions
Hepatitis B
Interventions
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)"

Trial Locations (1)

138-736

Department of clinical pharmacology and therapeutics, Seoul

Sponsors
All Listed Sponsors
lead

Green Cross Corporation

INDUSTRY