This is a Phase 1, open-label, dose escalation and dose expansion study to evaluate the safety, tolerability, PK, and antiviral activity of PBGENE-HBV in adult participants with chronic hepatitis B.
Male or women of non-child bearing potential
BMI 18.0 to 35.0
Good overall health deemed by the study Investigator
CHB infection documented at least 12 months prior to screening
No history of cirrhosis of the liver
No current infections of Hepatitis A, D, and E, human immunodeficiency virus (type 1 and 2), and no history of or current hepatitis C. In addition, no other active infections deemed clinically relevant.
No signs of hepatocellular carcinoma
Not received an organ transplant
Sequential
PBGENE-HBV
Biological/VaccinePBGENE-HBV is an in vivo gene editing intervention based on a novel proprietary ARCUS® platform designed to potentially cure chronic hepatitis B virus (HBV) by eliminating cccDNA, the key source of replicating hepatitis B virus, while also inactivating integrated HBV DNA in hepatocytes.
Safety to Assess Treatment-emergent Adverse Events (TEAEs)
Frequency of TEAEs
Additional Safety
Frequency and severity of adverse events and changes in physical examinations, vital signs, and safety labs (hematology, chemistry, and urinalysis)
Pharmacokinetics of AUC
Total PBGENE-HBV exposure over time
Pharmacokinetics of Cmax
Time at which Cmax (maximum peak concentration of PBGENE-HBV) is observed
Pharmacokinetics of Cmin
Minimum (or trough) concentration of PBGENE-HBV
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