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Phase 1 Study to Evaluate Safety and Antiviral Activity of PBGENE-HBV in Adult Patients With Chronic Hepatitis B
Sponsor: Precision BioSciences, Inc.
Summary
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.
Official title: A Phase 1, Open-Label, First-in-Human, Dose Escalation (Part 1) and Expansion (Part 2) Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of PBGENE-HBV in Participants With Chronic Hepatitis B (ELIMINATE-B)
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
45
Start Date
2024-11-14
Completion Date
2027-06
Last Updated
2026-08-24
Healthy Volunteers
No
Conditions
Interventions
PBGENE-HBV
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.
Locations (7)
Massachusetts General Hospital/Harvard University
Boston, Massachusetts, United States
Hospital Beaujon
Clichy, France, France
Queen Mary Hospital, The University of Hong Kong
Hong Kong, Hong Kong, Hong Kong
ICS ARENSIA Exploratory Medicine SRL
Chisinau, Moldova
New Zealand Clinical Research
Auckland, New Zealand
ARENSIA Exploratory Medicine
Bucharest, Romania, Romania
Arensia Exploratory Medicine in collaboration with County Clinical Emergency Hospital
Cluj-Napoca, Romania, Romania