Phase 1 Study to Evaluate Safety and Antiviral Activity of PBGENE-HBV in Adult Patients With Chronic Hepatitis B
Recruiting · NCT06680232 · Interventional (participants receive a specific treatment) · Lead sponsor: Precision BioSciences, Inc.
View the official record on ClinicalTrials.gov →Interventions studied
PBGENE-HBV
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.
Who can take part
Age range
18 Years to 70 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
7 locations listed across 1 US state.
- Massachusetts General Hospital/Harvard University - Boston, Massachusetts, United States
- New Zealand Clinical Research - Auckland, New Zealand
- ICS ARENSIA Exploratory Medicine SRL - Chisinau, Moldova
- Hospital Beaujon - Clichy, France, France
- Queen Mary Hospital, The University of Hong Kong - Hong Kong, Hong Kong, Hong Kong
- ARENSIA Exploratory Medicine - Bucharest, Romania, Romania
- Arensia Exploratory Medicine in collaboration with County Clinical Emergency Hospital - Cluj-Napoca, Romania, Romania