Recruiting
Phase 1

GIGA-2339

Sponsor:

GigaGen, Inc.

Code:

NCT07024641

Conditions

Hepatitis B Virus Infection

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

GIGA-2339

Placebo

Study Details

Brief 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.

Conditions

Hepatitis B Virus Infection

Study ID

NCT07024641

Start date

Nov 13, 2024

Status verified date

Jul, 2026

Completion date

Nov, 2028

Anticipated

Primary completion date

Nov, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

48 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part 1: Single Ascending Dose (SAD)

Participants will receive a single IV infusion of either GIGA-2339 or placebo in ascending doses on Day 1.

experimental: Part 2: Multiple Ascending Dose (MAD)

Participants will receive multiple IV infusions of either GIGA-2339 or placebo, once every 4 weeks, at a dose determined in Part 1.

Interventions

GIGA-2339

Administered by intravenous infusion

Placebo

Administered by intravenous infusion

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 ]

Central Contacts and Locations

Central contacts

Enrikas Vainorius, MD

+1 919-316-6396giga2339study@grifols.com

Locations

Grifols Investigative site

Recruiting

Chandler, Arizona, United States, 85225

Grifols Investigative site

Recruiting

Huntington Beach, California, United States, 92647

Grifols Investigative site

Recruiting

Lake Forest, California, United States, 92630

Grifols Investigative site

Recruiting

Long Beach, California, United States, 90805

Grifols Investigative Site

Recruiting

Peachtree Corners, Georgia, United States, 30071

Grifols Investigative Site

Recruiting

Iowa City, Iowa, United States, 52242

Grifols Investigative Site

Recruiting

Lenexa, Kansas, United States, 66219

Grifols Investigative site

Recruiting

Baltimore, Maryland, United States, 21287

Grifols Investigative site

Recruiting

San Antonio, Texas, United States, 78215

Grifols Investigative site

Recruiting

Webster, Texas, United States, 77598

Grifols Investigative site

Recruiting

Richmond, Virginia, United States, 23284

More Information

Sponsor

GigaGen, Inc.

Last update posted

Jul 17, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by GigaGen, Inc. on 2026-07-17.