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New hepatitis b drug enters first human tests

NCT ID NCT07024641

Disease control Sponsor: GigaGen, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jul 17, 2026 · Updated 2 times

Summary

This early-stage trial is testing an experimental drug called GIGA-2339 in 48 adults with chronic hepatitis B. The main goal is to check if the drug is safe and how the body processes it. Participants will receive either GIGA-2339 or a placebo by IV infusion, and researchers will monitor for side effects and measure drug levels in the blood.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
GIGA-2339 (an experimental drug given by IV infusion)
What this could lead to
If successful, this could lead to a new treatment option for chronic hepatitis B, potentially helping control the virus long-term.
What could go wrong
This is a very early Phase 1 trial with only 48 people, focused on safety and dosing. It is too soon to know if GIGA-2339 will effectively treat hepatitis B, and side effects are unknown.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 48 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2024

Expected to finish

Nov 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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).

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Conditions

The condition(s) this trial relates to.

chronic hepatitis B virus infection hepatitis B virus infection

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hepatitis B virus infection

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    19 sites in 5 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Grifols Investigate Site

    RECRUITING

    Concord, New South Wales, 2139, Australia

  • Grifols Investigative Site

    RECRUITING

    Peachtree Corners, Georgia, 30071, United States

  • Grifols Investigative Site

    RECRUITING

    Iowa City, Iowa, 52242, United States

  • Grifols Investigative Site

    RECRUITING

    Lenexa, Kansas, 66219, United States

  • Grifols Investigative site

    RECRUITING

    Chandler, Arizona, 85225, United States

  • Grifols Investigative site

    RECRUITING

    Huntington Beach, California, 92647, United States

  • Grifols Investigative site

    RECRUITING

    Lake Forest, California, 92630, United States

  • Grifols Investigative site

    RECRUITING

    Long Beach, California, 90805, United States

  • Grifols Investigative site

    SUSPENDED

    Oakland, California, 94605, United States

  • Grifols Investigative site

    RECRUITING

    Baltimore, Maryland, 21287, United States

  • Grifols Investigative site

    RECRUITING

    San Antonio, Texas, 78215, United States

  • Grifols Investigative site

    RECRUITING

    Webster, Texas, 77598, United States

  • Grifols Investigative site

    RECRUITING

    Richmond, Virginia, 23284, United States

  • Grifols Investigative site

    RECRUITING

    Fortitude Valley, Queensland, 4006, Australia

  • Grifols Investigative site

    RECRUITING

    Hong Kong, Hong Kong Island, Hong Kong

  • Grifols Investigative site

    RECRUITING

    Shatin, New Territories, Hong Kong

  • Grifols Investigative site

    RECRUITING

    Seogu, Busan, South Korea

  • Grifols Investigative site

    RECRUITING

    Songpa-dong, Seoul, South Korea

  • Grifols Investigative site

    RECRUITING

    Sanmin, Kaohsiung, Taiwan

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