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
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