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

GigaGen

Status and phase: Enrolling; Phase 1

Conditions: Hepatitis B Virus Infection

Treatments: Drug: GIGA-2339; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07024641

GC2301

Details and patient eligibility

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.

Enrollment: 48 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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48 participants in 2 patient groups

Part 1: Single Ascending Dose (SAD)

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: GIGA-2339

Part 2: Multiple Ascending Dose (MAD)

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: GIGA-2339