A Mechanistic Study of GSK3228836 With Fine Needle Aspiration (FNA) in Participants With Chronic Hepatitis B

Inclusion Criteria

• Participants should be at least 18 years of age at the time of signing the informed consent.
• Participants who have documented chronic HBV infection >=6 months prior to screening and currently receiving stable nucleos(t)ide analogue therapy, defined as no changes to their nucleos(t)ide regimen from at least 6 months prior to screening and with no planned changes to the stable regimen over the duration of the study.
• Plasma or serum HBsAg concentration >100 IU/mL
• Plasma or serum HBV DNA concentration must be adequately suppressed, defined as plasma or serum HBV DNA
• A confirmed menstrual period prior to the first dose of study intervention (additional evaluation [e.g. amenorrhea in athletes, birth control] should also be considered)
• and a negative highly sensitive pregnancy test (urine or serum) within 24 hours before the first dose of study treatment
• Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.

Exclusion Criteria

• Clinically significant abnormalities, aside from chronic HBV infection in medical history (e.g., moderate-severe liver disease other than chronic HBV, acute coronary syndrome within 6 months of screening, major surgery within 3 months of screening, significant/unstable cardiac disease, uncontrolled diabetes, bleeding diathesis or coagulopathy) or physical examination.
• Co-infection with:
• Current or past history of Hepatitis C virus (HCV)
• Human immunodeficiency virus (HIV)
• Hepatitis D virus (HDV).
• History of or suspected liver cirrhosis and/or evidence of cirrhosis as determined by
• Both Aspartate aminotransferase (AST)-Platelet Index (APRI) >2 and FibroSure/FibroTest result >0.7
• If only one parameter (APRI or FibroSure/FibroTest) result is positive, a discussion with the Medical Monitor is required before inclusion in study is permitted.
• Regardless of APRI or Fibrosure/FibroTest score participants will be excluded from the study if their past history includes one of the following criteria:
• Liver biopsy showing Metavir 4 or equivalent
• Liver stiffness >12 kilopascals (kPa)
• Diagnosed or suspected hepatocellular carcinoma as evidenced by the following
• Alpha-fetoprotein concentration >=200 nanograms (ng)/mL
• If the screening alpha fetoprotein concentration is >=50 ng/mL and =450 milliseconds (msec) (if single electrocardiogram [ECG] at screening shows QTcF >=450 msec, a mean of triplicate measurements should be used to confirm that participant meets exclusion criterion).
• Laboratory results as follows
• Serum albumin 1.25
• Platelet count 1.25 times ULN
• For participants with benign unconjugated hyperbilirubinemia with total bilirubin >1.25 times ULN, discussion for inclusion to the study is required with the Medical Monitor
• Urine albumin to creatinine ratio (ACR) >=0.03 mg/mg (or >=30 mg/g). In the event of an ACR above this threshold, eligibility may be confirmed by a second measurement 1) In cases where participants have low urine albumin and low urine creatinine levels resulting in a urine ACR calculation >=0.03 mg/mg (or >=30 mg/g), the investigator should confirm that the participant does not have a history of diabetes, hypertension or other risk factors that may affect renal function and discuss with the Medical Monitor, or designee.
• History of/sensitivity to GSK3228836 or components thereof or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation.