Phase
Condition
Hepatitis B
Hepatitis
Gynecological Infections
Treatment
GIGA-2339
Placebo
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 expectedto 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 highlyeffective contraception.
Female participants must not be pregnant, or breastfeeding; either should not be awoman of childbearing potential (WOCBP) or if WOCBP should use highly effectivecontraceptive methods.
Exclusion
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 cirrhosisevaluation 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, orautoimmune diseases that in the opinion of the investigator would precludeparticipation.
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 lesionon imaging 12 months prior to Screening OR, LI-RADS-US findings of US-3 grade onimaging 12 months prior to Screening, OR LIRADS-US grade 3 done prior to the D1infusion visit, if prior LI-RADS or LI-RADS-US results are not available atScreening.
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 withongoing treatment for malignancy, with the exception of localized non-metastaticbasal cell or squamous cell carcinoma of the skin or in-situ carcinoma of the cervixexcised with curative intent.
Participants requiring anti-coagulation therapies (for example warfarin, Factor Xainhibitors, 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 recordedat screening. Participants with evidence of intraventricular conduction delay,defined as QRS interval greater than 110 msec, will be excluded if the QTcF is > 500msec for both males and females.
Known hypersensitivity to any GIGA-2339 excipients or any confirmed significantallergic reactions (urticaria or anaphylaxis) against any drug, or multiple drugallergies (nonactive hay fever is acceptable), or a history of drug or other allergythat, 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 afteradministration of investigational product (IP).
Study Design
Connect with a study center
Grifols Investigative site
Chandler, Arizona 85225
United StatesActive - Recruiting
Grifols Investigative site
Huntington Beach, California 92647
United StatesActive - Recruiting
Grifols Investigative site
Lake Forest, California 92630
United StatesActive - Recruiting
Grifols Investigative site
Long Beach, California 90805
United StatesActive - Recruiting
Grifols Investigative Site
Peachtree Corners, Georgia 30071
United StatesActive - Recruiting
Grifols Investigative Site
Iowa City, Iowa 52242
United StatesActive - Recruiting
Grifols Investigative site
San Antonio, Texas 78215
United StatesActive - Recruiting
Grifols Investigative site
Webster, Texas 77598
United StatesActive - Recruiting
Grifols Investigative site
Richmond, Virginia 23284
United StatesActive - Recruiting
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