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Territories",{"type":44,"coordinates":206},[207,208],114.18333,22.38333,{"lat":208,"lon":207},[211],{"name":31,"role":32,"phone":25,"phoneExt":25,"email":25},{"facility":37,"status":38,"city":213,"state":214,"zip":25,"country":215,"cosmosGeoPoint":25,"geoPoint":25,"contacts":216},"Seogu","Busan","South Korea",[217],{"name":31,"role":32,"phone":25,"phoneExt":25,"email":25},{"facility":37,"status":38,"city":219,"state":220,"zip":25,"country":215,"cosmosGeoPoint":221,"geoPoint":225,"contacts":226},"Songpa-dong","Seoul",{"type":44,"coordinates":222},[223,224],127.12222,37.50139,{"lat":224,"lon":223},[227],{"name":31,"role":32,"phone":25,"phoneExt":25,"email":25},{"type":229,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100594837",false,"NCT07024641","A Study to Assess the Safety, Tolerability, and Pharmacokinetics of GIGA-2339 in Participants With Chronic Hepatitis B Virus Infection","A Randomized, 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spermatozoa and agree to use highly effective contraception.\n* 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.\n\nKey Exclusion Criteria:\n\n* Positive for co-infection with hepatitis C virus (HCV), human immunodeficiency virus (HIV), and\u002For hepatitis D virus (HDV) at screening.\n* Participants that weigh less than 50 kilograms (kg) and\u002For have a body mass index (BMI) less than 18.5.\n* History of documented liver cirrhosis at screening. Patients under liver cirrhosis evaluation at screening will not be eligible until cirrhosis is ruled out.\n* Liver stiffness \\> 8 kilopascal (kPa) at screening.\n* History of chronic liver disease from another cause, immune complex disease, or autoimmune diseases that in the opinion of the investigator would preclude participation.\n* Family history of hepatocellular carcinoma (HCC).\n* Alpha fetoprotein \\> 20 nanograms per milliliter (ng\u002FmL).\n* 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.\n* History of hematopoietic stem cell transplant or solid organ transplant.\n* Receipt of anti-HBV monoclonal antibody (mAb)\u002FpAb therapy of any kind in the past (including hepatitis B immunoglobulin \\[HBIG\\]).\n* History of cardiovascular disease (e.g., coronary artery disease, cardiomyopathy, congestive heart failure, family history of congenital long QT syndrome). Stable hypertension is allowed.\n* Malignancy diagnosed and\u002For treated within 5 years prior to Screening, and\u002For 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.\n* Participants requiring anti-coagulation therapies (for example warfarin, Factor Xa inhibitors, or anti-platelet agents like clopidogrel).\n* 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. if the participant has evidence of an intraventricular conduction delay, defined as QRS interval greater than 110 msec, a QTcF is \\> 500 msec for both males and females will be excluded.\n* 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.\n* 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).","ALL","18 Years",{"count":239,"type":240},48,"ESTIMATED","INTERVENTIONAL",[243],"PHASE1","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.",[246],"Hepatitis B Virus Infection","2026-06-23",{"date":249,"type":250},"2026-06-25","ACTUAL",{"date":252,"type":250},"2024-11-13",{"date":254,"type":240},"2028-11",{"name":5,"class":6},18]