計劃書編號GC2301
尚未開始召募
2026-03-08 - 2027-06-15
Phase I
尚未開始2
ICD-10B15.0
A型肝炎伴有肝昏迷
ICD-9070.0
A型病毒性肝炎併肝昏迷
一項隨機分配、雙盲、安慰劑對照、第1 期試驗，評估GIGA-2339 以單劑遞增劑量及多重遞增劑量對慢性B 型肝炎病毒感染受試者給藥之安全性、耐受性與藥物動力學
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試驗申請者
百瑞精鼎國際股份有限公司
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試驗委託 / 贊助單位名稱
百瑞精鼎國際股份有限公司
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臨床試驗規模
多國多中心
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更新日期
2026/02/01
試驗主持人及試驗醫院
適應症
慢性B 型肝炎
試驗目的
The primary purpose of this study is to assess the safety and tolerability of single and multiple intravenous (IV) doses of GIGA-2339 in participants with chronic Hepatitis B Virus (HBV) infection.
藥品名稱
溶液劑
主成份
GIGA-2339
劑型
18A
劑量
150mg/vial
評估指標
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
主要納入條件
•Hepatitis B envelope antigen (HBeAg) negative chronic HBV infection for ≥ 6 months, defined as presence of Hepatitis B surface antigen (HBsAg) in serum for ≥ 6 months.
•Serum HBsAg concentration between ≥ 100 international units per milliliter (IU/mL) and 2000 IU/mL at screening.
•Currently on stable dose of nucleot(s)ide analogues (NAs) (≥ 6 months) and expected to continue while in study.
•Serum HBV deoxyribonucleic acid (DNA) concentration ≤ 50 IU/mL at screening.
•Male participants must refrain from donating spermatozoa and agree to use highly effective contraception.
•Female participants must not be pregnant, or breastfeeding; either should not be a woman of childbearing potential (WOCBP) or if WOCBP should use highly effective contraceptive methods.
•Serum HBsAg concentration between ≥ 100 international units per milliliter (IU/mL) and 2000 IU/mL at screening.
•Currently on stable dose of nucleot(s)ide analogues (NAs) (≥ 6 months) and expected to continue while in study.
•Serum HBV deoxyribonucleic acid (DNA) concentration ≤ 50 IU/mL at screening.
•Male participants must refrain from donating spermatozoa and agree to use highly effective contraception.
•Female participants must not be pregnant, or breastfeeding; either should not be a woman of childbearing potential (WOCBP) or if WOCBP should use highly effective contraceptive methods.
主要排除條件
•Positive for co-infection with hepatitis C virus (HCV), human immunodeficiency virus (HIV), hepatitis D virus (HDV) at screening.
•Participants that weigh less than 50 kilograms (kg) and/or have a body mass index (BMI) less than 18.5.
•History of documented liver cirrhosis at screening. Patients under liver cirrhosis evaluation at screening will not be eligible until cirrhosis is ruled out.
•Liver stiffness > 8 kilopascal (kPa) at screening.
•History of chronic liver disease from another cause, immune complex disease, or autoimmune diseases that in the opinion of the investigator would preclude participation.
•Family history of hepatocellular carcinoma (HCC).
•Alpha fetoprotein > 20 nanograms per milliliter (ng/mL).
•Presence of a liver imaging reporting and data system (LI-RADS) 4 or 5 liver lesion on imaging 12 months prior to Screening OR, LI-RADS-US findings of US-3 grade on imaging 12 months prior to Screening, OR LIRADS-US grade 3 done prior to the D1 infusion visit, if prior LI-RADS or LI-RADS-US results are not available at Screening.
•History of hematopoietic stem cell transplant or solid organ transplant.
•Receipt of anti-HBV monoclonal antibody (mAb) therapy of any kind in the past (including hepatitis B immunoglobulin [HBIG]).
•History of cardiovascular disease (e.g., coronary artery disease, cardiomyopathy, congestive heart failure, family history of congenital long QT syndrome).
•Malignancy diagnosed and/or treated within 5 years prior to Screening, and/or with ongoing treatment for malignancy, with the exception of localized non-metastatic basal cell or squamous cell carcinoma of the skin or in-situ carcinoma of the cervix excised with curative intent.
•Participants requiring anti-coagulation therapies (for example warfarin, Factor Xa inhibitors, or anti-platelet agents like clopidogrel).
•Male participants with a corrected QT interval using Fridericia's formula (QTcF) > 450 milliseconds (msec) and female participants with QTcF > 470 msec on ECG recorded at screening. Participants with evidence of intraventricular conduction delay, defined as QRS interval greater than 110 msec, will be excluded if the QTcF is > 500 msec for both males and females.
•Known hypersensitivity to any GIGA-2339 excipients or any confirmed significant allergic reactions (urticaria or anaphylaxis) against any drug, or multiple drug allergies (nonactive hay fever is acceptable), or a history of drug or other allergy that, in the opinion of the Investigator, contraindicates participation.
•Received or will receive live-attenuated virus vaccinations such as measles, mumps, rubella or varicella within 4 weeks before and up to three months after administration of investigational product (IP).
•Participants that weigh less than 50 kilograms (kg) and/or have a body mass index (BMI) less than 18.5.
•History of documented liver cirrhosis at screening. Patients under liver cirrhosis evaluation at screening will not be eligible until cirrhosis is ruled out.
•Liver stiffness > 8 kilopascal (kPa) at screening.
•History of chronic liver disease from another cause, immune complex disease, or autoimmune diseases that in the opinion of the investigator would preclude participation.
•Family history of hepatocellular carcinoma (HCC).
•Alpha fetoprotein > 20 nanograms per milliliter (ng/mL).
•Presence of a liver imaging reporting and data system (LI-RADS) 4 or 5 liver lesion on imaging 12 months prior to Screening OR, LI-RADS-US findings of US-3 grade on imaging 12 months prior to Screening, OR LIRADS-US grade 3 done prior to the D1 infusion visit, if prior LI-RADS or LI-RADS-US results are not available at Screening.
•History of hematopoietic stem cell transplant or solid organ transplant.
•Receipt of anti-HBV monoclonal antibody (mAb) therapy of any kind in the past (including hepatitis B immunoglobulin [HBIG]).
•History of cardiovascular disease (e.g., coronary artery disease, cardiomyopathy, congestive heart failure, family history of congenital long QT syndrome).
•Malignancy diagnosed and/or treated within 5 years prior to Screening, and/or with ongoing treatment for malignancy, with the exception of localized non-metastatic basal cell or squamous cell carcinoma of the skin or in-situ carcinoma of the cervix excised with curative intent.
•Participants requiring anti-coagulation therapies (for example warfarin, Factor Xa inhibitors, or anti-platelet agents like clopidogrel).
•Male participants with a corrected QT interval using Fridericia's formula (QTcF) > 450 milliseconds (msec) and female participants with QTcF > 470 msec on ECG recorded at screening. Participants with evidence of intraventricular conduction delay, defined as QRS interval greater than 110 msec, will be excluded if the QTcF is > 500 msec for both males and females.
•Known hypersensitivity to any GIGA-2339 excipients or any confirmed significant allergic reactions (urticaria or anaphylaxis) against any drug, or multiple drug allergies (nonactive hay fever is acceptable), or a history of drug or other allergy that, in the opinion of the Investigator, contraindicates participation.
•Received or will receive live-attenuated virus vaccinations such as measles, mumps, rubella or varicella within 4 weeks before and up to three months after administration of investigational product (IP).
試驗計畫預計收納受試者人數
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台灣人數
10 人
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全球人數
48 人
