Clinical trial NCT07024641: A Study to Assess the Safety, Tolerability, and Pharmacokinetics of GIGA-2339 in Participants With Chronic Hepatitis B Virus Infection
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Hepatitis B Virus Infection
Lead sponsor: GigaGen, Inc.
Sponsor class: INDUSTRY
First posted: 2025-06-17
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


Eligibility 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 in study.
* Serum HBV deoxyribonucleic acid (DNA) concentration ≤ 50 IU/mL at screening.
* 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), 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) 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).
* 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. Participants with evidence of intraventricular conduction delay, defined as QRS interval greater than 110 msec, will be excluded if the QTcF is \> 500 msec for both males and females.
* 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).

Primary outcomes:
measure: SAD and MAD: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
timeFrame: SAD: Up to Day 105; MAD: Up to Day 245
Secondary outcomes:
measure: SAD and MAD: Maximum Serum Concentration (Cmax) of GIGA-2339
timeFrame: 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
measure: SAD and MAD: Area Under the Concentration Time Curve (AUC) from 0 to the Last Quantifiable Concentration (AUC0-t) of GIGA-2339
timeFrame: 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
measure: SAD: AUC From 0 to Infinity (AUC0-∞) of GIGA-2339
timeFrame: Pre-dose and at multiple timepoints post-dose up to Day 105
measure: SAD: Dose Normalized Maximum Serum Concentration (DN_Cmax). of GIGA-2339
timeFrame: Pre-dose and at multiple timepoints post-dose up to Day 105
measure: SAD: Dose Normalized AUC From 0 to the Last Quantifiable Concentration (DN_AUC0-t) of GIGA-2339
timeFrame: Pre-dose and at multiple timepoints post-dose up to Day 105
measure: SAD: Dose Normalized AUC From 0 to Infinity (DN_AUC0-∞) of GIGA-2339
timeFrame: Pre-dose and at multiple timepoints post-dose up to Day 105
measure: SAD and MAD: Time to Obtain Maximum Concentration (Tmax) of GIGA-2339
timeFrame: 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
measure: SAD and MAD: Terminal Half-Life (t1/2) of GIGA-2339
timeFrame: 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
measure: SAD and MAD: Volume of Distribution (Vz) of GIGA-2339
timeFrame: 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
measure: SAD and MAD: Systemic Clearance (CL) of GIGA-2339
timeFrame: 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
measure: MAD: Serum Concentration at the End of the Dosing Interval (Ctrough) of GIGA-2339
timeFrame: Pre-dose and at multiple timepoints post-dose up to Day 245
measure: MAD: AUC Versus Time Curve During the Dosing Interval (AUC0-tau) of GIGA-2339
timeFrame: Pre-dose and at multiple timepoints post-dose up to Day 245
measure: MAD: Accumulation Ratio Cmax (ARCmax) of GIGA-2339
timeFrame: Pre-dose and at multiple timepoints post-dose up to Day 245
measure: MAD: Accumulation Ratio AUC (ARAUCs) of GIGA-2339
timeFrame: Pre-dose and at multiple timepoints post-dose up to Day 245
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Grifols Investigative site
state: Arizona
city: Huntington Beach
country: United States
facility: Grifols Investigative site
state: California
city: Lake Forest
country: United States
facility: Grifols Investigative site
state: California
city: Long Beach
country: United States
facility: Grifols Investigative site
state: California
city: San Antonio
country: United States
facility: Grifols Investigative site
state: Texas
city: Webster
country: United States
facility: Grifols Investigative site
state: Texas
city: Richmond
country: United States
facility: Grifols Investigative site
state: Virginia
Study officials:
References: