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.
Refer to key Inclusion and Exclusion criteria.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
45
PBGENE-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.
Massachusetts General Hospital/Harvard University
Boston, Massachusetts, United States
RECRUITINGQueen Mary Hospital, The University of Hong Kong
Hong Kong, Hong Kong, Hong Kong
RECRUITINGICS ARENSIA Exploratory Medicine SRL
Chisinau, Moldova
Safety to Assess Treatment-emergent Adverse Events (TEAEs)
Frequency of TEAEs
Time frame: 4 weeks after final dose
Additional Safety
Frequency and severity of adverse events and changes in physical examinations, vital signs, and safety labs (hematology, chemistry, and urinalysis)
Time frame: 48 weeks
Pharmacokinetics of AUC
Total PBGENE-HBV exposure over time
Time frame: 4 weeks
Pharmacokinetics of Cmax
Time at which Cmax (maximum peak concentration of PBGENE-HBV) is observed
Time frame: 4 weeks
Pharmacokinetics of Cmin
Minimum (or trough) concentration of PBGENE-HBV
Time frame: 4 weeks
Pharmacokinetics of half life (t1/2)
Terminal half life
Time frame: 4 weeks
Antiviral Activity of HBsAg and Anti-HBs
Changes from baseline in hepatitis B surface antigen (HBsAg) and anti-HBs levels
Time frame: 48 weeks
Antiviral Activity of HBV DNA
Changes from baseline of HBV DNA
Time frame: 48 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
New Zealand Clinical Research
Auckland, New Zealand
RECRUITING