NCT01606163

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Aug 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 23, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 25, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2012

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

January 3, 2014

Status Verified

January 1, 2014

Enrollment Period

10 months

First QC Date

May 23, 2012

Last Update Submit

January 1, 2014

Conditions

Hepatitis B

Outcome Measures

Primary Outcomes (1)

  • 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

    screening, -1d, 1d, 2d, 3d, 4d, 5d, 6d, 7d, 8d, 9d, 14d, 21d, 28d

Secondary Outcomes (1)

  • Pharmacokinetics of GC1102 when repeatedly administered by intravenous injection to healthy male adults

    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

Study Arms (4)

group 1

EXPERIMENTAL

1. Drug:GC1102 2. Amount:3ml (30,000IU)

Biological: GC1102

group 2

EXPERIMENTAL

1. Drug: GC1102 2. Amount: 5ml(50,000IU)

Biological: GC1102

group 3

EXPERIMENTAL

1. Drug: GC1102 2. Amount: 8ml (80,000IU)

Biological: GC1102

group 4

PLACEBO COMPARATOR

drug: JW normal saline

Other: JW normal saline

Interventions

GC1102BIOLOGICAL

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)

Also known as: Hepabig_Gene
group 1group 2group 3
JW normal salineOTHER

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)

Also known as: saline solution
group 4

Eligibility Criteria

Age20 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of clinical pharmacology and therapeutics

Seoul, 138-736, South Korea

Location

MeSH Terms

Conditions

Hepatitis B

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Kyun-Seop Bae, MD, PhD

    Department of clinical pharmacology and therapeutics

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2012

First Posted

May 25, 2012

Study Start

August 1, 2012

Primary Completion

June 1, 2013

Study Completion

December 1, 2013

Last Updated

January 3, 2014

Record last verified: 2014-01

Locations

KR(1)