a phase 1 study of gc1102 (recombinant hepatitis b immunoglobulin) in chronic hepatitis b patients

Conditions: Chronic Hepatitis B

Summary: this study is sad(single ascending dose)/mad(multiple ascending dose) study to explore the tolerability, safety and pharmacokinetics/pharmacodynamics of gc1102 (recombinant hepatitis b human immunoglobulin) in chronic hepatitis b patients.

gc1102 is a new recombinant hepatitis b human immunoglobulin. this study is composed with 2 parts, part a for sad and part b for mad and total 4 dosing program which is escalated after confirming safety. maximum 48 subjects will be participated in the study.

Eligibility criteria:
inclusion criteria: * patients with chronic hepatitis b or those who diagnosed with chronic hepatitis b carrier who given written informed consent. * patients aged ≥19 and ≤ 65 years * if naïve for the nucleos(t)ide analogs therapy, hbeag (-), hbsag 1,000 iu/ml or less and hbv dna 2,000iu/ml or less or if currently receiving nucleos(t)ide analogs therapy, hbeag (±), hbsag 1,000 iu/ml or less and hbv dna (-: limit of detection of 60 iu/ml or less). 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.