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

October 13, 2017 updated by: Green Cross Corporation

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)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
53

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

15 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: GC1102 80,000 IU(Single does)
GC1102 80,000 IU(Single does) I.V.
Biological: GC1102
GC1102(Recombinant Hepatitis B Human Immunoglobulin)
Experimental: GC1102 120,000 IU(Single does)
GC1102 120,000 IU(Single does) I.V.
Biological: GC1102
GC1102(Recombinant Hepatitis B Human Immunoglobulin)
Experimental: GC1102 180,000 IU(Single does)
GC1102 180,000 IU(Single does) I.V.
Biological: GC1102
GC1102(Recombinant Hepatitis B Human Immunoglobulin)
Experimental: GC1102 240,000 IU(Single does)
GC1102 240,000 IU(Single does) I.V.
Biological: GC1102
GC1102(Recombinant Hepatitis B Human Immunoglobulin)
Experimental: GC1102 80,000 IU(Multiple does)
GC1102 80,000 IU(Multiple does) I.V.
Biological: GC1102
GC1102(Recombinant Hepatitis B Human Immunoglobulin)
Experimental: GC1102 120,000 IU(Multiple does)
GC1102 120,000 IU(Multiple does) I.V.
Biological: GC1102
GC1102(Recombinant Hepatitis B Human Immunoglobulin)
Experimental: GC1102 180,000 IU(Multiple does)
GC1102 180,000 IU(Multiple does) I.V.
Biological: GC1102
GC1102(Recombinant Hepatitis B Human Immunoglobulin)
Experimental: GC1102 240,000 IU(Multiple does)
GC1102 240,000 IU(Multiple does) I.V.
Biological: GC1102
GC1102(Recombinant Hepatitis B Human Immunoglobulin)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Dose Limiting Toxicity after the administration of GC1102
Time Frame: Part A: 4weeks, Part B: 7 weeks
Part A: 4weeks, Part B: 7 weeks
Adverse events after the administration of GC1102
Time Frame: Part A: 4weeks, Part B: 7 weeks
Part A: 4weeks, Part B: 7 weeks
Clinical findings in physical examination, vital signs and clinical laboratory after the administration of GC1102
Time Frame: Part A: 4weeks, Part B: 7 weeks
Part A: 4weeks, Part B: 7 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
HBsAg sero-conversion rate from positive to negative after the administration of GC1102 till End of Study visit
Time Frame: Part A: 4weeks, Part B: 7 weeks
Part A: 4weeks, Part B: 7 weeks
Geometric mean titer of serum HBsAg at each measurement point after the administration of GC1102
Time Frame: Part A: 4weeks, Part B: 7 weeks
Part A: 4weeks, Part B: 7 weeks
Geometric mean titer of serum HBV DNA of each measurement point after the administration of GC1102
Time Frame: Part A: 4weeks, Part B: 7 weeks
Part A: 4weeks, Part B: 7 weeks
Occurrence rate of anti-GC1102 antibody
Time Frame: Part A: 4weeks, Part B: 7 weeks
Part A: 4weeks, Part B: 7 weeks
Occurrence rate of HBV DNA sequence changes after the administration of GC1102
Time Frame: Part A: 4weeks, Part B: 7 weeks
Part A: 4weeks, Part B: 7 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
Ctrough for Part B
Time Frame: 7 weeks
7 weeks
Terminal elimination half-life (t½β)
Time Frame: Part A: 4weeks, Part B: 7 weeks
Part A: 4weeks, Part B: 7 weeks
Area under the time concentration curve from 0 to last and infinity (AUClast, AUC0-∞)
Time Frame: Part A: 4weeks, Part B: 7 weeks
Part A: 4weeks, Part B: 7 weeks
Maximum plasma concentration(Cmax)
Time Frame: Part A: 4weeks, Part B: 7 weeks
Part A: 4weeks, Part B: 7 weeks
Time to maximum plasma concentration (Tmax)
Time Frame: Part A: 4weeks, Part B: 7 weeks
Part A: 4weeks, Part B: 7 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Green Cross Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Sang-Hoon An, M.D., Severance Hospital
  • Study Director: Chin Kim, Green Cross Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 9, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 12, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 12, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 5, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 5, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 6, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 16, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 13, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GC1102B_P1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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