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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
36
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)
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)
Department of clinical pharmacology and therapeutics
Seoul, South Korea
Safety of GC1102 when repeatedly administered by intravenous injection to healthy male adults
* Adverse event * Diagnostic examinations * Physical examinations * Vital signs * ECG(electrocardiogram) * Check of concomitant drug
Time frame: screening, -1d, 1d, 2d, 3d, 4d, 5d, 6d, 7d, 8d, 9d, 14d, 21d, 28d
Pharmacokinetics of GC1102 when repeatedly administered by intravenous injection to healthy male adults
* Terminal elimination half-life (t½β) * Maximum and Average concentration at steady state(Cmax,ss, Cav,ss,) * Area-under the concentration-time curve within a dosing interval at steady state (AUCτ,ss) * Clearance (CL) * Volume of distribution at steady state (Vd,ss) * Mean residence time (MRT) * Accumulation Index (AI)
Time frame: 1)1d:predose(0h), 0.5, 1, 2, 5, 9, 14 hours after dose 2) 2d~6d:predose(0h) 3) 7d:predose(0h), 0.5, 1, 2, 5, 9, 14 hours after dose 4) 8d, 9d, 14d, 21d, 28d: 0h
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