Hepatitis BPhase 1NCT01606163
Safety and Pharmacokinetics Study of Healthy Male Adults When Repeatedly Administered Through Intravenous Injection
A Phase 1 study testing GC1102 and JW normal saline in people with Hepatitis B, run by Green Cross Corporation at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hepatitis B
- What is being tested?
- GC1102 and JW normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2012to Dec 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 19Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of clinical pharmacology and therapeutics
Seoul, 138-736
About this study
Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled, Multiple-dose, Dose Escalation Study to Assess the Safety and Pharmacokinetics of GC1102 (Hepabig-Gene) in Healthy Male Adults
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
- Being tested
- GC1102, JW normal saline
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GC1102Biological
Also called Hepabig_Gene
- Description: GC1102 IV bolus injection during 10~ 30 seconds.
- Amount: group1-3ml, group2-5ml, group3-8ml
- Subject number: group1-8, group2-8, group3-8
- Administration time: 1day, 2day, 3day, 4day, 5day, 6day, 7day(total: 7 times)
JW normal salineOther
Also called saline solution
- 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.
- Subject number: 9
- Administration time: 1day, 2day, 3day, 4day, 5day, 6day, 7day(total: 7 times)
| Study group | Role | What they receive |
|---|---|---|
| group 1 | Experimental | 1. Drug:GC1102
2. Amount:3ml (30,000IU) Receives: Biological: GC1102 |
| group 2 | Experimental | 1. Drug: GC1102
2. Amount: 5ml(50,000IU) Receives: Biological: GC1102 |
| group 3 | Experimental | 1. Drug: GC1102
2. Amount: 8ml (80,000IU) Receives: Biological: GC1102 |
| group 4 | Placebo comparator | drug: JW normal saline Receives: Other: JW normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
- 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)
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2012 (estimated)
- Study startAug 2012
- Primary completionJun 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis BStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Green Cross Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kyun-Seop Bae, MD, PhD, Principal investigator, Department of clinical pharmacology and therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01606163
- Sponsor's protocol ID
- GC1102
- Status last verified
- Jan 2014
- First submitted
- 23 May 2012
- Last updated
- 3 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-blind, Placebo-controlled, Multiple-dose, Dose Escalation Study to Assess the Safety and Pharmacokinetics of GC1102 (Hepabig-Gene) in Healthy Male Adults
- ClinicalTrials.gov ID
- NCT01606163
- Acronym / sponsor ID
- GC1102
- Conditions
- Hepatitis B
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Green Cross CorporationIndustry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 25 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| group 1 | Experimental | Biological: GC11021. Drug:GC1102 2. Amount:3ml (30,000IU) |
| group 2 | Experimental | Biological: GC11021. Drug: GC1102 2. Amount: 5ml(50,000IU) |
| group 3 | Experimental | Biological: GC11021. Drug: GC1102 2. Amount: 8ml (80,000IU) |
| group 4 | Placebo comparator | Other: JW normal salinedrug: JW normal saline |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GC1102Also: Hepabig_Gene1. 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) | Biological | group 1, group 2, group 3 |
| JW normal salineAlso: saline solution1. 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) | Other | group 4 |
Primary outcome
Safety of GC1102 when repeatedly administered by intravenous injection to healthy male adults
Time frame: screening, -1d, 1d, 2d, 3d, 4d, 5d, 6d, 7d, 8d, 9d, 14d, 21d, 28d
* Adverse event * Diagnostic examinations * Physical examinations * Vital signs * ECG(electrocardiogram) * Check of concomitant drug
1 secondary outcome
Pharmacokinetics of GC1102 when repeatedly administered by intravenous injection to healthy male adults
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kyun-Seop Bae, MD, PhD principal investigator
Department of clinical pharmacology and therapeutics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GC1102 and JW normal saline in people with Hepatitis B, run by Green Cross Corporation at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of GC1102 when repeatedly administered by intravenous injection to healthy male adults (time frame: screening, -1d, 1d, 2d, 3d, 4d, 5d, 6d, 7d, 8d, 9d, 14d, 21d, 28d). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2014.