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1. Pregnant or nursing females.
2. Male or female participants of childbearing potential unwilling to comply with contraception requirements during the study (Appendix 5).
3. Current, prior history, or is under evaluation for any of the following:
a) Difficulty with blood collection and/or poor venous access for the purposes of phlebotomy,
b) Clinical hepatic decompensation (i.e., ascites, encephalopathy variceal hemorrhage). Incidental small ascites on imaging without other clinical symptoms/signs of acute decompensation would not exclude the participants,
c) Hepatocellular carcinoma; suspected HCC on ultrasound at Screening,
d) Vasculitis,
e) Extrahepatic disorders possibly related to HBV immune complexes (e.g., glomerulonephritis, polyarteritis nodosa),
f) Solid organ or bone marrow transplantation,
g) Significant pulmonary disease (e.g., O2-dependent or forced expiratory volume 1 second (FEV1) ≤50% predicted value),
h) Significant cardiac disease (e.g., history of myocardial infarctions within 6 months, any history of ventricular tachycardia, congestive heart failure, dilated cardiomyopathy with left ventricular ejection fraction <40%),
i) Malignancy diagnosed or treated within 5 years (recent localized treatment of squamous or non-invasive basal cell skin cancers is permitted; cervical carcinoma in situ is allowed if appropriately treated prior to Screening).
4. CTP >6 (B or C) (see Section 6.7.7.2)
5. Presence of other liver disease(s) (non-HBV/HDV), such as metabolic dysfunction-associated steatohepatitis (MASH), alcohol associated hepatitis, cholestatic liver disease, other viral (e.g., HCV or HAV) or non-viral hepatitis that has the potential to impact interpretation of data. Exceptions to this criterion include fatty liver without any signs of steatohepatitis or past HCV infection that was successfully treated (HCV RNA negative) ≥6 months prior to Screening.
6. Uncontrolled human immunodeficiency virus (HIV) infection defined as having quantifiable HIV RNA levels in the blood at Screening.
7. History of hypersensitivity to any of the components in the brelovitug formulation.
8. Screening laboratory results as follows, or any other clinically significant abnormalities in Screening laboratory values that would render a participant unsuitable for inclusion:
a) Platelet count <50,000/mm3
b) Hemoglobin <10.0 g/dL
c) Creatinine clearance by Crockcroft-Gault (CrCl) <30 mL/min
d) Alpha fetoprotein (AFP) >100 ng/mL
9. Treatment with another investigational drug, a biological agent, or device within 4 weeks or 5 half-lives, whichever is longer, of Baseline.
10. Use of any interferon or bulevirtide within 12 weeks of Screening.
11. Use of any prohibited concomitant medications as described in Section 7.7.
12. Regular alcohol misuse, defined as weekly intake of ≥14 alcoholic drinks per week (average of ≥2 alcoholic drinks per day) within 12 months of Screening.
13. Clinically relevant drug abuse (not including cannabis) within 12 months of Screening.
14. Unwillingness to comply with study procedures as specified by this protocol, or unwillingness to cooperate fully with the Investigator.
15. Have any other conditions (medical, social, psychiatric, or other), which in the opinion of the Investigator would make the participant unsuitable for inclusion or could interfere with the participant participating in or completing the study.
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