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GIGA-2339: safety and drug behavior testing in people with chronic hepatitis B

A Randomized, Double-Blind, Placebo-Controlled, Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of GIGA-2339 Administered as a Single Ascending Dose and Multiple Ascending Doses in Participants With Chronic Hepatitis B Virus Infection

Phase 1 Interventional GigaGen, Inc. · NCT07024641

This trial tests single and multiple IV doses of GIGA-2339 versus placebo to see if they are safe and well tolerated in adults with chronic hepatitis B.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment48 (estimated)
Ages18 Years and up
SexAll
SponsorGigaGen, Inc. Industry-sponsored
Locations16 sites (Chandler, Arizona and 15 other locations)
Trial IDNCT07024641 on ClinicalTrials.gov

What this trial studies

This Phase 1 randomized, placebo-controlled trial gives single and multiple intravenous doses of GIGA-2339 to adults with chronic hepatitis B to characterize safety, tolerability, and pharmacokinetics. The study collects serial blood samples for drug levels and closely monitors for adverse events. Eligible participants are HBeAg-negative with specified HBsAg and HBV DNA ranges and may be on stable nucleos(t)ide analogue therapy or not. Dosing and follow-up take place at investigational sites in Arizona and California to gather early human safety and PK data.

Who should consider this trial

Good fit: Ideal candidates are adults with HBeAg-negative chronic HBV, HBsAg 100–2000 IU/mL, HBV DNA within the specified limits, able to continue or remain off nucleos(t)ide analogues per criteria, and who can attend visits at the U.S. study sites and follow contraception requirements.

Not a fit: Patients who are HBeAg-positive, pregnant or breastfeeding, have HBV DNA above the allowed thresholds, or who cannot comply with site visits and contraceptive restrictions are unlikely to benefit from participation.

Why it matters

Potential benefit: If safe and well tolerated, this could identify appropriate dosing and enable later studies that might lead to a new treatment option for chronic hepatitis B.

How similar studies have performed: Similar early-phase antibody and novel-agent trials for HBV have had mixed results, and this specific agent is a novel approach that is unproven in humans.

Eligibility criteria

Show full inclusion / exclusion criteria 
Key Inclusion Criteria:

* 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.

Key Exclusion Criteria:

* 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).

Where this trial is running

Chandler, Arizona and 15 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Hepatitis B Virus Infection
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.