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

NCT01606163 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2014-01-03

No results posted yet for this study

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

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)

Sponsors & Collaborators

  • Green Cross Corporation

    lead INDUSTRY

Principal Investigators

  • Kyun-Seop Bae, MD, PhD · Department of clinical pharmacology and therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2013-06-30
Completion
2013-12-31

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01606163 on ClinicalTrials.gov