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

NCT07024641 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: GC2301
• Study Type: interventional
• Target: 48
• Locations: 3 countries
• Sites: 16

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

Outcome Measures

Primary Outcomes (1)

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

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

Secondary Outcomes (14)

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

  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

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

  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

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

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

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

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

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

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

Study Arms (2)

Part 1: Single Ascending Dose (SAD)

EXPERIMENTAL

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

Drug: GIGA-2339; Drug: Placebo

Part 2: Multiple Ascending Dose (MAD)

EXPERIMENTAL

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

Drug: GIGA-2339; Drug: Placebo

Interventions

GIGA-2339 DRUG

Administered by intravenous infusion

Part 1: Single Ascending Dose (SAD); Part 2: Multiple Ascending Dose (MAD)

Placebo DRUG

Administered by intravenous infusion

Part 1: Single Ascending Dose (SAD); Part 2: Multiple Ascending Dose (MAD)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GigaGen, Inc.: lead

Study Sites (16)

Grifols Investigative site

Chandler, Arizona, 85225, United States

RECRUITING

Grifols Investigative site

Huntington Beach, California, 92647, United States

RECRUITING

Grifols Investigative site

Lake Forest, California, 92630, United States

RECRUITING

Grifols Investigative site

Long Beach, California, 90805, United States

RECRUITING

Grifols Investigative site

Oakland, California, 94605, United States

RECRUITING

Grifols Investigative Site

Peachtree Corners, Georgia, 30071, United States

RECRUITING

Grifols Investigative Site

Iowa City, Iowa, 52242, United States

RECRUITING

Grifols Investigative Site

Lenexa, Kansas, 66219, United States

RECRUITING

Grifols Investigative site

Baltimore, Maryland, 21287, United States

RECRUITING

Grifols Investigative site

San Antonio, Texas, 78215, United States

RECRUITING

Grifols Investigative site

Webster, Texas, 77598, United States

RECRUITING

Grifols Investigative site

Richmond, Virginia, 23284, United States

RECRUITING

Grifols Investigate Site

Concord, New South Wales, 2139, Australia

RECRUITING

Grifols Investigative site

Fortitude Valley, Queensland, 4006, Australia

RECRUITING

Grifols Investigative site

Hong Kong, Hong Kong Island, Hong Kong

RECRUITING

Grifols Investigative site

Shatin, New Territories, Hong Kong

RECRUITING

MeSH Terms

Conditions

Hepatitis B

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

Central Study Contacts

Enrikas Vainorius, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2025
• First Posted: June 17, 2025
• Study Start: November 13, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: March 18, 2026

Record last verified: 2026-03

Locations

AU (2); HK (2); US (12)