Actively Recruiting
A Randomized, Double-Blind, Placebo-Controlled Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of GIGA-2339 Given as Single and Multiple Intravenous Doses in Adults With Chronic Hepatitis B Virus Infection
Led by GigaGen, Inc. · Updated on 2026-05-22
48
Participants Needed
17
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating the safety and tolerability of GIGA-2339, given as single and multiple intravenous doses, in adults with chronic Hepatitis B Virus (HBV) infection. This Phase 1, randomized, double-blind, placebo-controlled study aims to better understand how the drug behaves in the body and its safety profile in participants with this long-term viral infection. Participants receive either a single intravenous infusion of GIGA-2339 or placebo in ascending doses on Day 1. In the multiple ascending dose part, they receive repeated infusions every 4 weeks at a dose determined from the single dose part. The study has two parts: Part 1 assesses single ascending doses and Part 2 evaluates multiple ascending doses of the study drug or placebo. Throughout the study, participants undergo regular safety assessments, including monitoring for any treatment-emergent or serious adverse events up to Day 105 for single doses and Day 245 for multiple doses. Blood samples are collected at various times to measure drug levels and pharmacokinetics. The study lasts several months, with detailed evaluations of how the drug is processed in the body and its potential side effects.
CONDITIONS
Brief 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
- Hepatitis B envelope antigen (HBeAg) negative chronic HBV infection for at least 6 months, confirmed by presence of Hepatitis B surface antigen (HBsAg) in serum for at least 6 months
- Serum HBsAg concentration between 100 IU/mL and 2000 IU/mL at screening
- Currently on a stable dose of nucleot(s)ide analogues for at least 6 months and expected to continue during the study, or not receiving nucleot(s)ide analogues
- Serum HBV DNA concentration ≤ 50 IU/mL if on nucleot(s)ide analogues, or ≤ 2000 IU/mL if not on nucleot(s)ide analogues
- Male participants must agree to use highly effective contraception and refrain from sperm donation
- Female participants must not be pregnant or breastfeeding; must either not be women of childbearing potential or use highly effective contraceptive methods
You will not qualify if you...
- Positive for co-infection with hepatitis C virus, HIV, or hepatitis D virus at screening
- Weigh less than 50 kilograms or have a body mass index less than 18.5
- History of documented liver cirrhosis or currently under evaluation for cirrhosis
- Liver stiffness greater than 8 kilopascal at screening
- History of chronic liver disease from other causes, immune complex disease, or autoimmune diseases that may prevent participation
- Family history of hepatocellular carcinoma
- Alpha fetoprotein level greater than 20 nanograms per milliliter
- Presence of liver lesions classified as LI-RADS 4 or 5, or US-3 grade on imaging within 12 months prior to screening
- History of hematopoietic stem cell or solid organ transplant
- Previous treatment with anti-HBV monoclonal or polyclonal antibody therapy
- History of cardiovascular disease such as coronary artery disease, cardiomyopathy, congestive heart failure, or congenital long QT syndrome; stable hypertension allowed
- Recent malignancy diagnosed or treated within 5 years, except certain localized skin or cervical cancers
- Need for anti-coagulation therapies
- Abnormal corrected QT interval on ECG above specified limits
- Known hypersensitivity to GIGA-2339 excipients or significant allergic reactions contraindicating participation
- Recent live-attenuated virus vaccinations within 4 weeks before and up to 3 months after investigational product administration
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 35 weeks depending on dosing schedule
Participants receive either a single intravenous infusion or multiple intravenous infusions of GIGA-2339 or placebo to evaluate safety, tolerability, and pharmacokinetics.
1 single infusion visit for Part 1; or multiple infusions once every 4 weeks for up to 6 months in Part 2
Duration - Up to 14 weeks after last treatment
Participants are monitored for treatment-emergent adverse events and other safety assessments after the last infusion.
Multiple visits for safety assessments up to Day 105 for Part 1 and up to Day 245 for Part 2
Trial Site Locations
Total: 17 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
17
Grifols Investigative site
Seogu, Busan, South Korea
Actively Recruiting
Research Team
E
Enrikas Vainorius, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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