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

NCT02569372 | Completed Phase 1 DMC

• 1 other identifier: GC1102B_P1
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Hepatitis B

Outcome Measures

Primary Outcomes (3)

• 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

• Clinical findings in physical examination, vital signs and clinical laboratory after the administration of GC1102

  Part A: 4weeks, Part B: 7 weeks

Secondary Outcomes (5)

• 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

Other Outcomes (5)

• Ctrough for Part B

  7 weeks

• Terminal elimination half-life (t½β)

  Part A: 4weeks, Part B: 7 weeks

• Area under the time concentration curve from 0 to last and infinity (AUClast, AUC0-∞)

  Part A: 4weeks, Part B: 7 weeks

Study Arms (8)

GC1102 80,000 IU(Single does)

EXPERIMENTAL

GC1102 80,000 IU(Single does) I.V.

Biological: GC1102

GC1102 120,000 IU(Single does)

EXPERIMENTAL

GC1102 120,000 IU(Single does) I.V.

Biological: GC1102

GC1102 180,000 IU(Single does)

EXPERIMENTAL

GC1102 180,000 IU(Single does) I.V.

Biological: GC1102

GC1102 240,000 IU(Single does)

EXPERIMENTAL

GC1102 240,000 IU(Single does) I.V.

Biological: GC1102

GC1102 80,000 IU(Multiple does)

EXPERIMENTAL

GC1102 80,000 IU(Multiple does) I.V.

Biological: GC1102

GC1102 120,000 IU(Multiple does)

EXPERIMENTAL

GC1102 120,000 IU(Multiple does) I.V.

Biological: GC1102

GC1102 180,000 IU(Multiple does)

EXPERIMENTAL

GC1102 180,000 IU(Multiple does) I.V.

Biological: GC1102

GC1102 240,000 IU(Multiple does)

EXPERIMENTAL

GC1102 240,000 IU(Multiple does) I.V.

Biological: GC1102

Interventions

GC1102 BIOLOGICAL

GC1102(Recombinant Hepatitis B Human Immunoglobulin)

GC1102 120,000 IU(Multiple does); GC1102 120,000 IU(Single does); GC1102 180,000 IU(Multiple does); GC1102 180,000 IU(Single does); GC1102 240,000 IU(Multiple does); GC1102 240,000 IU(Single does); GC1102 80,000 IU(Multiple does); GC1102 80,000 IU(Single does)

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Green Cross Corporation: lead

Study Sites (1)

Severance Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Sang-Hoon An, M.D.

  Severance Hospital

  PRINCIPAL INVESTIGATOR

• Chin Kim

  Green Cross Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2015
• First Posted: October 6, 2015
• Study Start: November 9, 2015
• Primary Completion: October 12, 2017
• Study Completion: October 12, 2017
• Last Updated: October 16, 2017

Record last verified: 2017-10

Locations

KR (1)