Actively Recruiting
Phase 1 Study to Evaluate Safety and Antiviral Activity of PBGENE-HBV in Adult Patients With Chronic Hepatitis B
Led by Precision BioSciences, Inc. · Updated on 2025-09-26
45
Participants Needed
4
Research Sites
106 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Phase 1 Study to Evaluate Safety and Antiviral Activity of PBGENE-HBV in Adult Patients With Chronic Hepatitis B
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or women of non-child bearing potential
- Body Mass Index (BMI) between 18.0 and 35.0
- Good overall health as determined by the study investigator
- Chronic hepatitis B infection documented at least 12 months before screening
- Hepatitis B e antigen (HBeAg)-negative chronic hepatitis B
- Currently virologically suppressed on nucleos(t)ide analogue treatment
You will not qualify if you...
- History of liver cirrhosis
- Current infection with hepatitis A, D, or E, HIV type 1 or 2, or hepatitis C, or any other active clinically relevant infection
- Signs of hepatocellular carcinoma
- Previous organ transplant
- Any malignancy within 5 years before screening except specific cancers cured by surgery (e.g., basal cell skin cancer)
- Use of any investigational agent within 6 months before screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Massachusetts General Hospital/Harvard University
Boston, Massachusetts, United States, 02114
Actively Recruiting
2
Queen Mary Hospital, The University of Hong Kong
Hong Kong, Hong Kong, Hong Kong
Actively Recruiting
3
ICS ARENSIA Exploratory Medicine SRL
Chisinau, Moldova, 2025
Actively Recruiting
4
New Zealand Clinical Research
Auckland, New Zealand, 1010
Actively Recruiting
Research Team
P
Precision Trial Manager
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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