A Study to Assess the Safety, Tolerability, and Pharmacokinetics of GIGA-2339 in Participants With Chronic Hepatitis B Virus Infection

Last updated: May 20, 2026
Sponsor: GigaGen, Inc.
Overall Status: Active - Recruiting

Phase

1

Condition

Hepatitis

Gynecological Infections

Liver Disorders

Treatment

GIGA-2339

Placebo

Clinical Study ID

NCT07024641
GC2301
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 expectedto 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 atscreening (for those who are NOT on NAs).

  • Male participants must refrain from donating spermatozoa and agree to use highlyeffective contraception.

  • Female participants must not be pregnant, or breastfeeding; either should not be awoman of childbearing potential (WOCBP) or if WOCBP should use highly effectivecontraceptive methods.

Exclusion

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 cirrhosisevaluation 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, orautoimmune diseases that in the opinion of the investigator would precludeparticipation.

  • 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 lesionon imaging 12 months prior to Screening OR, LI-RADS-US findings of US-3 grade onimaging 12 months prior to Screening, OR LIRADS-US grade 3 done prior to the D1infusion visit, if prior LI-RADS or LI-RADS-US results are not available atScreening.

  • 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). Stablehypertension is allowed.

  • Malignancy diagnosed and/or treated within 5 years prior to Screening, and/or withongoing treatment for malignancy, with the exception of localized non-metastaticbasal cell or squamous cell carcinoma of the skin or in-situ carcinoma of the cervixexcised with curative intent.

  • Participants requiring anti-coagulation therapies (for example warfarin, Factor Xainhibitors, 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 recordedat screening. if the participant has evidence of an intraventricular conductiondelay, defined as QRS interval greater than 110 msec, a QTcF is > 500 msec for bothmales and females will be excluded.

  • Known hypersensitivity to any GIGA-2339 excipients or any confirmed significantallergic reactions (urticaria or anaphylaxis) against any drug, or multiple drugallergies (nonactive hay fever is acceptable), or a history of drug or other allergythat, 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 afteradministration of investigational product (IP).

Study Design

Total Participants: 48
Treatment Group(s): 2
Primary Treatment: GIGA-2339
Phase: 1
Study Start date:
November 13, 2024
Estimated Completion Date:
November 30, 2028

Connect with a study center

  • Grifols Investigate Site

    Concord, New South Wales 2139
    Australia

    Active - Recruiting

  • Grifols Investigate Site

    Concord 2170852, New South Wales 2155400 2139
    Australia

    Site Not Available

  • Grifols Investigative site

    Fortitude Valley, Queensland 4006
    Australia

    Active - Recruiting

  • Grifols Investigative site

    Fortitude Valley 6943577, Queensland 2152274 4006
    Australia

    Site Not Available

  • Grifols Investigative site

    Hong Kong, Hong Kong Island
    Hong Kong

    Active - Recruiting

  • Grifols Investigative site

    Hong Kong 1819729, Hong Kong Island
    Hong Kong

    Site Not Available

  • Grifols Investigative site

    Shatin, New Territories
    Hong Kong

    Active - Recruiting

  • Grifols Investigative site

    Seogu, Busan
    South Korea

    Active - Recruiting

  • Grifols Investigative site

    Chandler, Arizona 85225
    United States

    Active - Recruiting

  • Grifols Investigative site

    Chandler 5289282, Arizona 5551752 85225
    United States

    Site Not Available

  • Grifols Investigative site

    Huntington Beach, California 92647
    United States

    Active - Recruiting

  • Grifols Investigative site

    Lake Forest, California 92630
    United States

    Active - Recruiting

  • Grifols Investigative site

    Long Beach, California 90805
    United States

    Active - Recruiting

  • Grifols Investigative site

    Oakland, California 94605
    United States

    Active - Recruiting

  • Grifols Investigative site

    Huntington Beach 5358705, California 5332921 92647
    United States

    Site Not Available

  • Grifols Investigative site

    Lake Forest 5364514, California 5332921 92630
    United States

    Site Not Available

  • Grifols Investigative site

    Long Beach 5367929, California 5332921 90805
    United States

    Site Not Available

  • Grifols Investigative site

    Oakland 5378538, California 5332921 94605
    United States

    Site Not Available

  • Grifols Investigative Site

    Peachtree Corners, Georgia 30071
    United States

    Active - Recruiting

  • Grifols Investigative Site

    Peachtree Corners 4215114, Georgia 4197000 30071
    United States

    Site Not Available

  • Grifols Investigative Site

    Iowa City, Iowa 52242
    United States

    Active - Recruiting

  • Grifols Investigative Site

    Iowa City 4862034, Iowa 4862182 52242
    United States

    Site Not Available

  • Grifols Investigative Site

    Lenexa, Kansas 66219
    United States

    Active - Recruiting

  • Grifols Investigative Site

    Lenexa 4274356, Kansas 4273857 66219
    United States

    Site Not Available

  • Grifols Investigative site

    Baltimore, Maryland 21287
    United States

    Active - Recruiting

  • Grifols Investigative site

    Baltimore 4347778, Maryland 4361885 21287
    United States

    Site Not Available

  • Grifols Investigative site

    San Antonio, Texas 78215
    United States

    Active - Recruiting

  • Grifols Investigative site

    Webster, Texas 77598
    United States

    Active - Recruiting

  • Grifols Investigative site

    San Antonio 4726206, Texas 4736286 78215
    United States

    Site Not Available

  • Grifols Investigative site

    Webster 4740423, Texas 4736286 77598
    United States

    Site Not Available

  • Grifols Investigative site

    Richmond, Virginia 23284
    United States

    Active - Recruiting

  • Grifols Investigative site

    Richmond 4781708, Virginia 6254928 23284
    United States

    Site Not Available

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