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

NCT ID: NCT01606163

Last Updated: 2014-01-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2013-12-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

group 1

1. Drug:GC1102

2. Amount:3ml (30,000IU)

Group Type: EXPERIMENTAL

GC1102

Intervention Type: BIOLOGICAL

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)

group 2

1. Drug: GC1102

2. Amount: 5ml(50,000IU)

Group Type: EXPERIMENTAL

GC1102

Intervention Type: BIOLOGICAL

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)

group 3

1. Drug: GC1102

2. Amount: 8ml (80,000IU)

Group Type: EXPERIMENTAL

GC1102

Intervention Type: BIOLOGICAL

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)

group 4

drug: JW normal saline

Group Type: PLACEBO_COMPARATOR

JW normal saline

Intervention Type: OTHER

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)

Interventions

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)

Intervention Type: BIOLOGICAL

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)

Intervention Type: OTHER

Other Intervention Names

Hepabig_Gene; saline solution

Eligibility Criteria

Inclusion Criteria

• Those who are healthy, male adult aged 20 years- 45 years when screened.
• Those whose body weights are over 45kg when screened, and whose BMI scores are 19kg/㎡-28 kg/㎡.
• Those whose HBs-Ag, HBc-Ab(IgM), HBc-Ab(IgG), HBV DNA quantitative are all negative when screened.
• Those whose HBs-Ab(titer) in blood is below 500 IU/L when screened.
• Those who agree to use double protective contraceptive measures from one days before administration of first investigative drug to last follow-up visit(protective contraceptive measures using more than 2 ways among a male condom, a female condom of sex partner, a spermicide of sex partner, an intrauterine device(IUD) of sex partner, a diaphragm of sex partner and a cervical cap of sex partner), and not to provide sperm.
• Those who voluntarily decide to follow matters that require attention of this study and give written consent to participate in this clinical trial.
• Those who can visit the medical center to be monitored, and agree to collect blood during study period.

Exclusion Criteria

• Those who have GC1102 anti-body when screened
• Those who have a clinically meaningful disease or history concerning liver, kidney, alimentary system, respiratory system, musculoskeletal system, endocrine system, neuropsychiatry system, blood tumor system, cardiovascular system.
• Those who have anaphylaxis of drug allergy including HBIG or who have allergy disease requiring treatment.
• Those who have immunodeficiency disease now.
• Those who have an anamnesis of Guillain-Barre syndrome.
• Hemophiliac patients who have a risk of serious bleeding when getting a shot through intravascular injection or those who are being administered anticoagulants
• Those who are administered live vaccine parenterally within 120 days from being administered first investigative drug. (ex: measles vaccine, epidemic parotitis vaccine, rubella vaccine, cholera vaccine, chickenpox vaccine)
• Those who are administered interferon or antiviral agents within 120 days from being administered first investigative drug. (except for topical medication)
• Those who showed signs of an acute fever(over 38℃) within 72 hours from being administered first investigative drug.
• Those who showed signs of acute disease within 14 days from being administered first investigative drug.
• Those who donated whole blood within 60 days or ingredient blood within 30 days from being administered first investigative drug or those who are administered blood transfusion within 30 days from being administered first investigative drug.
• Those who took other investigative drugs within 60 days from being administered first investigative drug.
• Those who took herbal medicine within 30 days from being administered first investigative drug or took ethical drug(ETC) within 14 days or took over-the- counter drug(OTC) within 7 days from being administered first investigative drug.(but, Those who meet other conditions can join the clinical trials according to investigator's decision)
• Those who drink excessively caffeine-contained beverage, excessive alcohol, and who are smokers( caffeine> 5 units/ day, alcohol>21 units/ week, cigarette> 10 pieces) or have a history of alcoholism
• Those who have a history of drug addiction, or showed positive response of urine-drug screening examination (ex: amphetamine, methamphetamine, barbiturate, cocaine, opiate, benzodiazepines, cannabinoid, methadone, etc)
• Those who showed positive sign of serum test(A-type hepatitis test(HAV IgM Ab), C-type hepatitis test(HCV Ab screening), HIV test(HIV Ag & Ab), Syphilis high quality reagin test.
• Those whose serum creatinine, ALT, AST, or total bilirubin exceeded the standard 1.5 times by the diagnostic lab test.
• Those who cannot eat standard meals provided by Seoul Asan medical center.
• Those who are judged disqualified to join clinical trials by investigator for other causes.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Green Cross Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kyun-Seop Bae, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of clinical pharmacology and therapeutics

Locations

Department of clinical pharmacology and therapeutics

Seoul, , South Korea

Countries

South Korea

Other Identifiers

GC1102

Identifier Type: -

Identifier Source: org_study_id