A Phase 1 Study to Assess the Safety and Pharmacokinetics of GC1102 (Hepabig-Gene) in Healthy Male Adults
- Conditions
- Not Applicable
- Registration Number
- KCT0000473
- Lead Sponsor
- Green Cross
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- Male
- Target Recruitment
- 33
1)Those who are healthy, male adult aged 20 years- 45 years when
screened.
2)Those whose body weights are over 45kg when screened, and whose BMI
scores are 19kg/?-28 kg/?.
3)Those whose HBs-Ag, HBc-Ab(IgM), HBc-Ab(IgG), HBV DNA quantitative are
all negative when screened.
4)Those whose HBs-Ab(titer) in blood are below 500 IU/L when screened.
5)Those who agree to use double protective contraceptive measures from
one days before administering 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.
6)Those who voluntarily decide to follow matters that require attention
of this study and give written consent to participate in this
clinical trial.
7)Those who can visit the medical center to be monitored, and agree to
collect blood during study period.
1)Those who have GC1102 anti-body when screened
2)Those who have a clinically meaningful disease or history concerning
liver, kidney, alimentary system, respiratory system, musculoskeletal
sytem, endocrine system, neuropsychiatry system, blood tumor system,
cardiovascular system.
3)Those who have anaphylaxis of drug allergy including HBIG or who have
allergy disease requiring treatment.
4)Those who have immunodeficiency disease now.
5)Those who have a history of anamnesis of Guillain-Barre syndrome.
6)Hemophiliac patients who have a risk of serious bleeding when getting
a shot through intravascular injection or those who are being
administered anticoagulants
7)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)
8)Those who are administered interferon or antiviral agents within 120
days from being administered first investigative drug. (except for
topical medication)
9)Those who showed signs of an acute fever(over 38?) within 72 hours
from being administered first investigative drug.
10)Those who showed signs of acute disease within 14 days from being
administered first investigative drug.
11)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.
12)Those who took other investigative drugs within 60 days from being
administered first investigative drug.
13)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)
14)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
15)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)
16)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.
17)Those whose serum creatinine, ALT, AST, or total bilirubin exceeded
the standard 1.5 times by the diagnostic lab test.
18)Those who cannot eat standard meals provided by Seoul Asan medical
center.
19)Those who are judged disqualified to join clinical trials by
investigator for other causes.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Adverse event;Diagnostic examinations;Physical examinations;Vital signs;ECG(electrocardiogram);Check of concomitant drug
- Secondary Outcome Measures
Name Time Method Terminal elimination half-life (t½ß); Maximum and Average concentration at steady state(Cmax,ss, Cav,ss,); Area-under the concentration-time curve within a dosing interval at steady state (AUCt,ss); Clearance (CL); Volume of distribution at steady state (Vd,ss); Mean residence time (MRT); Accumulation Index (AI)