KCT0000473
Not yet recruiting
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 sites33 target enrollmentTBD
ConditionsNot Applicable
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not Applicable
- Sponsor
- Green Cross
- Enrollment
- 33
- Status
- Not yet recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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