KCT0000473尚未招募未知
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.
Green Cross0 个研究点目标入组 33 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 33
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 20(Year) 至 45(Year)（—）
- 性别
- Male
入选标准
- •1)Those who are healthy, male adult aged 20 years- 45 years when
- •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
- •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.
排除标准
- •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
- •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
- •19)Those who are judged disqualified to join clinical trials by
- •investigator for other causes.
研究者
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