A Study of GIGA-2339 for Chronic Hepatitis B Virus Infection
This study is testing a new drug called GIGA-2339 for people with chronic Hepatitis B Virus (HBV) infection. Researchers want to see how safe GIGA-2339 is and how well your body handles it when given through an IV (intravenous infusion). Some participants will receive GIGA-2339, while others will receive a placebo (an inactive substance). To join, you must be at least 18 years old and have chronic HBV infection for at least 6 months, with specific levels of Hepatitis B surface antigen (HBsAg) in your blood. The main goal is to track any side effects you might experience. The study aims to enroll 48 participants, but its current recruitment status is unclear.
- Study design
- This interventional study plans to enroll 48 participants. It compares GIGA-2339 to a placebo, both given by intravenous infusion.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be monitored for side effects for up to 105 days after a single dose and up to 245 days after multiple doses.
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NCT07024641
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of GIGA-2339 in Participants With Chronic Hepatitis B Virus Infection
Recruiting
PHASE1Ages 18+InterventionalTreatmentGigaGen, Inc.
~48 participants
Updated 2026-07-17 on ClinicalTrials.gov
What's tested:GIGA-2339Placebo
At a glance
Recruiting sites
18 of 19 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
SAD and MAD: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Measured over SAD: Up to Day 105; MAD: Up to Day 245
Conditions
Where it's being run
19 sites across 15 statesCalifornia4
Texas2
Arizona1
Georgia1
Iowa1
Kansas1
Maryland1
Virginia1
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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 participating in the study, or are not received NAs.
Have serum HBV deoxyribonucleic acid (DNA) concentration ≤ 50 IU/mL at screening (for those who are on NAs); or have serum HBV DNA concentration ≤ 2000 IU/mL at screening (for those who are NOT on NAs).
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.
Exclusion
Positive for co-infection with hepatitis C virus (HCV), human immunodeficiency virus (HIV), and/or 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)/pAb 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). Stable hypertension is allowed.
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. 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.
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).
What this trial measures
- SAD and MAD: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)SAD: Up to Day 105; MAD: Up to Day 245