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453
A Prospective, Open-Label, Dose-Escalation,
Single-Center, Phase 1 Study for GC1102, a
Recombinant Human Immunoglobulin for
Chronic Hepatitis B Patients
Hye Won Lee1, Jun Yong Park2, Taegon Hong3, Min Soo Park4
and Sang Hoon Ahn2, (1)Department of Internal Medicine,
Yonsei University College of Medicine, (2)Yonsei Liver Center,
Severance Hospital, (3)Department of Clinical Pharmacology,
Yonsei University College of Medicine, (4)Department of
Pediatrics, Yonsei University College of Medicine
Background: Existing treatment with antiviral drugs
eliminates hepatitis B virus (HBV) DNA but not hepatitis B
surface antigen (HBsAg). GC1102 is a recombinant human
hepatitis B immunoglobulin and expected to boost therapeutic
effects by improving the sustained virological response
through reduction of the blood HBsAg level. This study aimed
to evaluate the safety and efficacy of GC1102 with single
and multiple intravenous administrations in chronic hepatitis
B (CHB) patients. Methods: This study was designed as a
prospective, open-label, sequential group dose-escalation,
and single-center study in treatment groups. There were two
groups with single administration (Part A, n=24) and multiple
(4 times of weekly) administrations (Part B, n=29) of GC1102,
which had 80,000 IU, 120,000 IU, 180,000 IU, and 240,000
IU, to CHB patients who had ≤1,000 IU/mL serum HBsAg.
The period of treatment and observation for each subject was
4 weeks for Part A and 7 weeks for Part B. Results: According
to the result of analysis on safety and tolerability, no dose
limiting toxicity has occurred at all doses so it is considered
favorable. No adverse drug reaction was observed up to
the 120,000 IU group of both Part A and B. A few adverse
events (flushing, nausea, and dizziness) were observed in
the 240,000 IU group and all are mild and transient. HBsAg
loss occurred in 12.5% (1/8) in the 80,000 IU group and
22.2% (2/9) in the 240,000 IU group of Part B. And HBsAg
titer was dramatically declined after each administration and
increased value at 28 days after except for 3 subjects who
experienced HBsAg loss. Conclusion: The tolerability and
safety of GC1102 are considered favorable in CHB patients.
Concomitant administration of GC1102 and antivirals is
expected to have durable efficacy in patients with HBsAg titer
≤1,000 IU/mL and to increase a functional curative chance in
CHB patients.
Disclosures:
Sang Hoon Ahn – Green Cross Corp.: Grant/Research Support
The following people have nothing to disclose: Hye Won Lee, Jun Yong Park
Disclosure information not available at the time of publication: Taegon Hong,
Min Soo Park
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发表于 2018-10-22 16:29
