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

RECRUITINGPHASE1

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

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

NCT07024641•GigaGen, Inc.

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

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 \[HBIG\]).
+6 more criteria

Locations (16)

Grifols Investigative site

Chandler, Arizona, United States

Grifols Investigative site

Huntington Beach, California, United States

Grifols Investigative site

Lake Forest, California, United States

Grifols Investigative site

Long Beach, California, United States

Grifols Investigative site

Oakland, California, United States

Grifols Investigative Site

Peachtree Corners, Georgia, United States

Grifols Investigative Site

Iowa City, Iowa, United States

Grifols Investigative Site

Lenexa, Kansas, United States

Grifols Investigative site

Baltimore, Maryland, United States

Grifols Investigative site

San Antonio, Texas, United States

Key Dates

Start Date

November 13, 2024

Primary Completion Date

September 1, 2027

Completion Date

September 1, 2027

Last Updated

March 18, 2026

Enrollment

ESTIMATED participants

Conditions

Hepatitis B Virus Infection

Interventions

GIGA-2339

DRUG

Placebo

DRUG

Contacts

Enrikas Vainorius, MD

CONTACT

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

Treatment and Prognosis of Patients With Chronic HBV Infection

NCT05392387

Hepatitis B Virus Infection

View study

ACTIVE_NOT_RECRUITINGPHASE2

A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)

NCT06537414

Chronic Hepatitis B Virus InfectionHepatitis B

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 18, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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