RECRUITING

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

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2024-11-13

Study Completion:2027-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07024641

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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).

Inclusion Criteria

Exclusion 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.

* 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).

Contacts and Locations

Study Contact

Laurie Han-Conrad

CONTACT

+34 93 5710500

giga2339study@grifols.com

Study Locations (Sites)

Grifols Investigative site

Chandler, Arizona, 85225

United States

Grifols Investigative site

Huntington Beach, California, 92647

United States

Grifols Investigative site

Lake Forest, California, 92630

United States

Grifols Investigative site

Long Beach, California, 90805

United States

Grifols Investigative site

San Antonio, Texas, 78215

United States

Grifols Investigative site

Webster, Texas, 77598

United States

Grifols Investigative site

Richmond, Virginia, 23284

United States

Collaborators and Investigators

Sponsor: GigaGen, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-13

Study Completion Date2027-09

Study Record Updates

Study Start Date2024-11-13

Study Completion Date2027-09

Terms related to this study

Additional Relevant MeSH Terms

Hepatitis B Virus Infection