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NCT06680232PHASE1Recruiting

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

Precision BioSciences, Inc.

Start Date

11/14/2024

Completion Date

12/1/2026

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.

Detailed Description

Refer to key Inclusion and Exclusion criteria.

Eligibility Criteria

Age Range: 18 years to 70 years

Key Inclusion Criteria: * 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 * HBeAg-negative CHB * Must be virologically suppressed on current NA treatment Key Exclusion Criteria: * 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 * No malignancy within 5 years of screening, except for specific cancers that are cured by surgical resection (e.g., basal cell skin cancer) * No investigational agent received within 6 months of screening

Interventions

BIOLOGICAL

PBGENE-HBV

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Conditions

HEPATITIS B CHRONIC

Locations

Massachusetts General Hospital/Harvard University

Boston, Massachusetts 02114

United States

Queen Mary Hospital, The University of Hong Kong

Hong Kong, Hong Kong

Hong Kong

ICS ARENSIA Exploratory Medicine SRL

Chisinau, 2025

Moldova

New Zealand Clinical Research

Auckland, 1010

New Zealand