Actively Recruiting
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of GIGA-2339 in Participants With Chronic Hepatitis B Virus Infection
Led by GigaGen, Inc. · Updated on 2026-03-18
48
Participants Needed
16
Research Sites
146 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of GIGA-2339 in Participants With Chronic Hepatitis B Virus Infection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- HBeAg negative chronic Hepatitis B Virus infection for 6 months or more, confirmed by presence of HBsAg in serum
- Serum HBsAg concentration between 100 IU/mL and 2000 IU/mL at screening
- On stable dose of nucleos(t)ide analogues for at least 6 months and expected to continue during study, or not receiving nucleos(t)ide analogues
- Serum HBV DNA concentration 4 IU/mL if on nucleos(t)ide analogues; or 2000 IU/mL if not on nucleos(t)ide analogues
- Male participants agree to use highly effective contraception and refrain from sperm donation
- Female participants must not be pregnant or breastfeeding and either not be women of childbearing potential or use highly effective contraception if they are
You will not qualify if you...
- Positive for co-infection with hepatitis C virus, HIV, or hepatitis D virus
- Weigh less than 50 kilograms or have a body mass index less than 18.5
- History or evaluation suggesting liver cirrhosis
- Liver stiffness greater than 8 kilopascal at screening
- Chronic liver disease from other causes, immune complex disease, or autoimmune diseases that would prevent participation
- Family history of hepatocellular carcinoma
- Alpha fetoprotein greater than 20 ng/mL
- Liver lesions classified as LI-RADS 4 or 5, or LI-RADS-US grade 3 on imaging within 12 months prior to screening
- History of hematopoietic stem cell or solid organ transplant
- Previous anti-HBV monoclonal or polyclonal antibody therapy, including hepatitis B immunoglobulin
- History of cardiovascular disease such as coronary artery disease, cardiomyopathy, or congestive heart failure; stable hypertension allowed
- Malignancy diagnosed or treated within 5 years prior to screening except localized non-metastatic skin or in-situ cervical carcinoma treated curatively
- Requiring anticoagulation therapy
- Abnormal ECG with QTcF above specified thresholds or intraventricular conduction delay
- Known hypersensitivity to GIGA-2339 components or significant drug allergies
- Receipt of live-attenuated virus vaccines within 4 weeks before and up to 3 months after investigational product administration
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 16 locations
1
Grifols Investigative site
Chandler, Arizona, United States, 85225
Actively Recruiting
2
Grifols Investigative site
Huntington Beach, California, United States, 92647
Actively Recruiting
3
Grifols Investigative site
Lake Forest, California, United States, 92630
Actively Recruiting
4
Grifols Investigative site
Long Beach, California, United States, 90805
Actively Recruiting
5
Grifols Investigative site
Oakland, California, United States, 94605
Actively Recruiting
6
Grifols Investigative Site
Peachtree Corners, Georgia, United States, 30071
Actively Recruiting
7
Grifols Investigative Site
Iowa City, Iowa, United States, 52242
Actively Recruiting
8
Grifols Investigative Site
Lenexa, Kansas, United States, 66219
Actively Recruiting
9
Grifols Investigative site
Baltimore, Maryland, United States, 21287
Actively Recruiting
10
Grifols Investigative site
San Antonio, Texas, United States, 78215
Actively Recruiting
11
Grifols Investigative site
Webster, Texas, United States, 77598
Actively Recruiting
12
Grifols Investigative site
Richmond, Virginia, United States, 23284
Actively Recruiting
13
Grifols Investigate Site
Concord, New South Wales, Australia, 2139
Actively Recruiting
14
Grifols Investigative site
Fortitude Valley, Queensland, Australia, 4006
Actively Recruiting
15
Grifols Investigative site
Hong Kong, Hong Kong Island, Hong Kong
Actively Recruiting
16
Grifols Investigative site
Shatin, New Territories, Hong Kong
Actively Recruiting
Research Team
E
Enrikas Vainorius, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here