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Hepatitis B Virus InfectionPhase 1NCT07024641

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

A Phase 1 study testing GIGA-2339 in people with Hepatitis B Virus Infection, run by GigaGen, Inc. at 20 sites in 5 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatitis B Virus Infection
What is being tested?
GIGA-2339
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
48 participants
Where
20 sitesin 5 countries
Study dates
13 Nov 2024to Nov 2028
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).
Show all 16Show fewer
  • 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).

Trial locations and contacts

20 sites in 5 countries. Contact the study team or a site near you to ask about taking part.

Enrikas Vainorius, MD contact

+1 919-316-6396

giga2339study@grifols.com

20 sites in 5 countries

United States12 sites, 11 recruiting

  • Grifols Investigative site

    Baltimore, Maryland, 21287

    Enrikas Vainorius, MD

    Recruiting

  • Grifols Investigative site

    Chandler, Arizona, 85225

    Enrikas Vainorius, MD

    Recruiting

  • Grifols Investigative site

    Huntington Beach, California, 92647

    Enrikas Vainorius, MD

    Recruiting

  • Grifols Investigative Site

    Iowa City, Iowa, 52242

    Enrikas Vainorius, MD

    Recruiting

  • Grifols Investigative site

    Lake Forest, California, 92630

    Enrikas Vainorius, MD

    Recruiting

  • Grifols Investigative Site

    Lenexa, Kansas, 66219

    Enrikas Vainorius, MD

    Recruiting

  • Grifols Investigative site

    Long Beach, California, 90805

    Enrikas Vainorius, MD

    Recruiting

  • Grifols Investigative site

    Oakland, California, 94605

    Suspended

  • Grifols Investigative Site

    Peachtree Corners, Georgia, 30071

    Enrikas Vainorius, MD

    Recruiting

  • Grifols Investigative site

    Richmond, Virginia, 23284

    Enrikas Vainorius, MD

    Recruiting

  • Grifols Investigative site

    San Antonio, Texas, 78215

    Enrikas Vainorius, MD

    Recruiting

  • Grifols Investigative site

    Webster, Texas, 77598

    Enrikas Vainorius, MD

    Recruiting

Other trials in United States

Australia2 sites, 2 recruiting

  • Grifols Investigate Site

    Concord, New South Wales, 2139

    Enrikas Vainorius, MD

    Recruiting

  • Grifols Investigative site

    Fortitude Valley, Queensland, 4006

    Enrikas Vainorius, MD

    Recruiting

Other trials in Australia

Hong Kong2 sites, 2 recruiting

  • Grifols Investigative site

    Hong Kong, Hong Kong Island

    Enrikas Vainorius, MD

    Recruiting

  • Grifols Investigative site

    Shatin, New Territories

    Enrikas Vainorius, MD

    Recruiting

Other trials in Hong Kong

South Korea2 sites, 2 recruiting

  • Grifols Investigative site

    Seogu, Busan

    Enrikas Vainorius, MD

    Recruiting

  • Grifols Investigative site

    Songpa-dong, Seoul

    Enrikas Vainorius, MD

    Recruiting

Other trials in South Korea

Taiwan2 sites, 2 recruiting

  • Grifols Investigative site

    Sanmin, Kaohsiung

    Enrikas Vainorius, MD

    Recruiting

  • Grifols Investigative site

    Zhongzheng, Taipei

    Enrikas Vainorius, MD

    Recruiting

Other trials in Taiwan

About this study

Official title: 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

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.

Being tested
GIGA-2339, Placebo
Medical subject headings
Hepatitis B

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GIGA-2339Drug

    Administered by intravenous infusion

  • PlaceboDrug

    Administered by intravenous infusion

Study groups in NCT07024641
Study groupRoleWhat they receive
Part 1: Single Ascending Dose (SAD)ExperimentalParticipants will receive a single IV infusion of either GIGA-2339 or placebo in ascending doses on Day 1.
Receives: Drug: GIGA-2339; Drug: Placebo
Part 2: Multiple Ascending Dose (MAD)ExperimentalParticipants will receive multiple IV infusions of either GIGA-2339 or placebo, once every 4 weeks, at a dose determined in Part 1.
Receives: Drug: GIGA-2339; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. SAD and MAD: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

    Measured: SAD: Up to Day 105; MAD: Up to Day 245

Secondary outcomes (14)

  1. SAD and MAD: Maximum Serum Concentration (Cmax) of GIGA-2339

    Measured: SAD: Pre-dose and at multiple timepoints post-dose up to Day 105; MAD: Pre-dose and at multiple timepoints post-dose up to Day 245

  2. SAD and MAD: Area Under the Concentration Time Curve (AUC) from 0 to the Last Quantifiable Concentration (AUC0-t) of GIGA-2339

    Measured: SAD: Pre-dose and at multiple timepoints post-dose up to Day 105; MAD: Pre-dose and at multiple timepoints post-dose up to Day 245

  3. SAD: AUC From 0 to Infinity (AUC0-∞) of GIGA-2339

    Measured: Pre-dose and at multiple timepoints post-dose up to Day 105

  4. SAD: Dose Normalized Maximum Serum Concentration (DN_Cmax). of GIGA-2339

    Measured: Pre-dose and at multiple timepoints post-dose up to Day 105

  5. SAD: Dose Normalized AUC From 0 to the Last Quantifiable Concentration (DN_AUC0-t) of GIGA-2339

    Measured: Pre-dose and at multiple timepoints post-dose up to Day 105

  6. SAD: Dose Normalized AUC From 0 to Infinity (DN_AUC0-∞) of GIGA-2339

    Measured: Pre-dose and at multiple timepoints post-dose up to Day 105

  7. SAD and MAD: Time to Obtain Maximum Concentration (Tmax) of GIGA-2339

    Measured: SAD: Pre-dose and at multiple timepoints post-dose up to Day 105; MAD: Pre-dose and at multiple timepoints post-dose up to Day 245

  8. SAD and MAD: Terminal Half-Life (t1/2) of GIGA-2339

    Measured: SAD: Pre-dose and at multiple timepoints post-dose up to Day 105; MAD: Pre-dose and at multiple timepoints post-dose up to Day 245

  9. SAD and MAD: Volume of Distribution (Vz) of GIGA-2339

    Measured: SAD: Pre-dose and at multiple timepoints post-dose up to Day 105; MAD: Pre-dose and at multiple timepoints post-dose up to Day 245

  10. SAD and MAD: Systemic Clearance (CL) of GIGA-2339

    Measured: SAD: Pre-dose and at multiple timepoints post-dose up to Day 105; MAD: Pre-dose and at multiple timepoints post-dose up to Day 245

  11. MAD: Serum Concentration at the End of the Dosing Interval (Ctrough) of GIGA-2339

    Measured: Pre-dose and at multiple timepoints post-dose up to Day 245

  12. MAD: AUC Versus Time Curve During the Dosing Interval (AUC0-tau) of GIGA-2339

    Measured: Pre-dose and at multiple timepoints post-dose up to Day 245

  13. MAD: Accumulation Ratio Cmax (ARCmax) of GIGA-2339

    Measured: Pre-dose and at multiple timepoints post-dose up to Day 245

  14. MAD: Accumulation Ratio AUC (ARAUCs) of GIGA-2339

    Measured: Pre-dose and at multiple timepoints post-dose up to Day 245

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jun 2025
  2. Study start13 Nov 2024
  3. Primary completionNov 2028 (estimated)
  4. Study completionNov 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
48 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07024641
Sponsor's protocol ID
GC2301
Status last verified
Sep 2026
First submitted
30 Apr 2025
Last updated
25 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GIGA-2339 in people with Hepatitis B Virus Infection, run by GigaGen, Inc. at 20 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in United States, Australia, Hong Kong, South Korea, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Enrikas Vainorius, MD (+1 919-316-6396, giga2339study@grifols.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

SAD and MAD: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (time frame: SAD: Up to Day 105; MAD: Up to Day 245). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07024641.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.

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