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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02569372
Other study ID # GC1102B_P1
Secondary ID
Status Completed
Phase Phase 1
First received October 5, 2015
Last updated October 13, 2017
Start date November 9, 2015
Est. completion date October 12, 2017

Study information

Verified date October 2017
Source Green Cross Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 information / eligibility

Status Completed
Enrollment 53
Est. completion date October 12, 2017
Est. primary completion date October 12, 2017
Accepts healthy volunteers No
Gender All
Age group 19 Years to 65 Years
Eligibility 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


Intervention

Biological:
GC1102
GC1102(Recombinant Hepatitis B Human Immunoglobulin)

Locations

Country Name City State
Korea, Republic of Severance Hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
Green Cross Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Other Ctrough for Part B 7 weeks
Other Terminal elimination half-life (t½ß) Part A: 4weeks, Part B: 7 weeks
Other Area under the time concentration curve from 0 to last and infinity (AUClast, AUC0-8) Part A: 4weeks, Part B: 7 weeks
Other Maximum plasma concentration(Cmax) Part A: 4weeks, Part B: 7 weeks
Other Time to maximum plasma concentration (Tmax) Part A: 4weeks, Part B: 7 weeks
Primary Dose Limiting Toxicity after the administration of GC1102 Part A: 4weeks, Part B: 7 weeks
Primary Adverse events after the administration of GC1102 Part A: 4weeks, Part B: 7 weeks
Primary Clinical findings in physical examination, vital signs and clinical laboratory after the administration of GC1102 Part A: 4weeks, Part B: 7 weeks
Secondary 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
Secondary Geometric mean titer of serum HBsAg at each measurement point after the administration of GC1102 Part A: 4weeks, Part B: 7 weeks
Secondary Geometric mean titer of serum HBV DNA of each measurement point after the administration of GC1102 Part A: 4weeks, Part B: 7 weeks
Secondary Occurrence rate of anti-GC1102 antibody Part A: 4weeks, Part B: 7 weeks
Secondary Occurrence rate of HBV DNA sequence changes after the administration of GC1102 Part A: 4weeks, Part B: 7 weeks
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