NCT02569372已完成1 期
A Prospective, Open-label, Dose-escalation, Single-center, Phase I Trial to Explore the Tolerability, Safety and Pharmacokinetics/Pharmacodynamics of GC1102 (Recombinant Hepatitis B Human Immunoglobulin)
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Clinical findings in physical examination, vital signs and clinical laboratory after the administration of GC1102
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
研究组 & 干预措施
GC1102 120,000 IU(Single does)
Experimental
GC1102 120,000 IU(Single does) I.V.
干预措施: GC1102 (Biological)
GC1102 180,000 IU(Multiple does)
Experimental
GC1102 180,000 IU(Multiple does) I.V.
干预措施: GC1102 (Biological)
GC1102 120,000 IU(Multiple does)
Experimental
GC1102 120,000 IU(Multiple does) I.V.
干预措施: GC1102 (Biological)
GC1102 80,000 IU(Single does)
Experimental
GC1102 80,000 IU(Single does) I.V.
干预措施: GC1102 (Biological)
GC1102 240,000 IU(Single does)
Experimental
GC1102 240,000 IU(Single does) I.V.
干预措施: GC1102 (Biological)
GC1102 80,000 IU(Multiple does)
Experimental
GC1102 80,000 IU(Multiple does) I.V.
干预措施: GC1102 (Biological)
GC1102 180,000 IU(Single does)
Experimental
GC1102 180,000 IU(Single does) I.V.
干预措施: GC1102 (Biological)
GC1102 240,000 IU(Multiple does)
Experimental
GC1102 240,000 IU(Multiple does) I.V.
干预措施: GC1102 (Biological)
结局指标
主要结局
Clinical findings in physical examination, vital signs and clinical laboratory after the administration of GC1102
时间窗: Part A: 4weeks, Part B: 7 weeks
Dose Limiting Toxicity after the administration of GC1102
时间窗: Part A: 4weeks, Part B: 7 weeks
Adverse events after the administration of GC1102
时间窗: Part A: 4weeks, Part B: 7 weeks
次要结局
- HBsAg sero-conversion rate from positive to negative after the administration of GC1102 till End of Study visit(Part A: 4weeks, Part B: 7 weeks)
- Geometric mean titer of serum HBsAg at each measurement point after the administration of GC1102(Part A: 4weeks, Part B: 7 weeks)
- Geometric mean titer of serum HBV DNA of each measurement point after the administration of GC1102(Part A: 4weeks, Part B: 7 weeks)
- Occurrence rate of anti-GC1102 antibody(Part A: 4weeks, Part B: 7 weeks)
- Occurrence rate of HBV DNA sequence changes after the administration of GC1102(Part A: 4weeks, Part B: 7 weeks)
研究者
研究点 (1)
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