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RECRUITING
NCT06680232
PHASE1

Phase 1 Study to Evaluate Safety and Antiviral Activity of PBGENE-HBV in Adult Patients With Chronic Hepatitis B

Sponsor: Precision BioSciences, Inc.

View on ClinicalTrials.gov

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

2026-12

Last Updated

2025-09-26

Healthy Volunteers

No

Interventions

BIOLOGICAL

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 (4)

Massachusetts General Hospital/Harvard University

Boston, Massachusetts, United States

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