A Phase 1 Study of GC1102 (Recombinant Hepatitis B Immunoglobulin) in Chronic Hepatitis B Patients

Exclusion Criteria

• •Patients who currently involved or has participated in any other clinical trial within 30 days.
• •Patients co-infected with HAV, HCV or HIV
• •Patients with history of malignant tumor within 5 years except basal cell carcinoma of skin, cervical intraepithelial neoplasia.
• •Patients who have active infection except chronic hepatitis infection.
• •Patients with liver disease who had complications such as gastroesophageal variceal, ascites and hepatic encephalopathy.
• •Having eGFR 59 mL/min/1.73m2 or less with MDRD Evaluation phase (moderate reduction in GFR or more )
• •Having blood or protein 1+ or more by the urine analysis with microscopic examination.
• •Patients who have a clinically significant kidney disease including glomerulonephritis, anuria, acute renal failure, dialysis and renal transplantation.
• •Patients with Vasculitis.
• •Having leukocytes \<3.0 x109/L
• •Having Absolute Neutrophil Count\<1.5x109/L
• •Having platelet \<750,000/mm3 during screening
• •Having hemoglobin \<10g/dL
• •Having positive sign of serum cryoglobulin level.
• •Having serum anti-nuclear antibody (ANA) 1:160 or more
• •Patients who showed positive sign of serum perinuclear anti-Neutrophil Cytoplasmic Antibodies (p-ANCA).
• •Patients who showed positive sign of serum cytoplasmic anti-Neutrophil Cytoplasmic Antibodies (c-ANCA).
• •Patients who had history or be suspected of immune disease
• •Patients who had experienced cardiovascular attack, myocardiac infarction, heart failure, PTCA or coronary artery bypass, angina, arrhythmia, any other clinically meaningful valvular heart disease, cerebral infarction or cerebral hemorrhage within 6 months.
• •Patients who had history of anaphylaxis against the main component or subcomponent of study drug.
• •Patients who had been administered live vaccine parentally (measles vaccine, parotitis vaccine, rubella vaccine, cholera combined vaccine, varicella vaccine) within 3 months prior to the dosing of study drug.
• •Patients who had been received an immunosuppressant, immunity-modifying drug including interferon agents, cytotoxic chemotherapy that can affect their immune system, or radiation therapy within 3 months prior to the dosing of study drug
• •Patients who had been treated with any other immunoglobulin within 3 months prior to the dosing of study drug
• •Patients who had been treated with systemic steroid Therapy(more than 20 mg/day of prednisolone or its equivalence administered every day for more than 14 days, or more than 700 mg of a cumulative dose during the same period of time) within 3 months prior to the dosing of study drug (topical administration such as topical ointments, eye drops, inhalants or intranasal use, intra-articular injection, or tendon injection is acceptable; alternative-day treatment is acceptable even though administered for more than 14 days)
• •Women who showed positive sign of pregnancy test before administered study drug.
• •Those who do not agree to use appropriate contraceptive methods (condom, diaphoretic, an intrauterine device, oral contraceptive hormones, or a vasectomy of male sex partner) during the clinical trials.
• •Those who had experienced bleeding more 400ml or a blood donation within 8 weeks prior to the dosing of study drug.
• •Those who had been abused alcohol or any other drug within 6 months.
• •Those who are judged disqualified to join clinical trials by investigator for other clinically significant medical or psychiatric condition.