A Phase 1 Study of GC1102 (Recombinant Hepatitis B Immunoglobulin) in Chronic Hepatitis B Patients
Phase 1
Completed
- Conditions
- Chronic Hepatitis B
- Registration Number
- NCT02569372
- Lead Sponsor
- Green Cross Corporation
- Brief 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 53
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Clinical findings in physical examination, vital signs and clinical laboratory after the administration of GC1102 Part A: 4weeks, Part B: 7 weeks Dose Limiting Toxicity after the administration of GC1102 Part A: 4weeks, Part B: 7 weeks Adverse events after the administration of GC1102 Part A: 4weeks, Part B: 7 weeks
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Severance Hospital
🇰🇷Seoul, Korea, Republic of
Severance Hospital🇰🇷Seoul, Korea, Republic of