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Recruiting Phase 1 NCT06680232

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

Phase 1 – testing safety in a small group of people
Conditions: HEPATITIS B CHRONIC

Sponsor: Precision BioSciences, Inc.

trial.available_in: БГ
Overview
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.
Description
Refer to key Inclusion and Exclusion criteria.
Who can participate
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
Locations 4
Hong Kong (1)
Queen Mary Hospital, The University of Hong Kong
Hong Kong , Hong Kong
Man-Fung Yuen, MBBS, MD, PhD, DSc
Moldova (1)
ICS ARENSIA Exploratory Medicine SRL
Chisinau
Manager, Projects & Research Logistics
New Zealand (1)
New Zealand Clinical Research
Auckland
United States (1)
Massachusetts General Hospital/Harvard University
Boston , Massachusetts
Technical details
Status
Recruiting
Phase
Phase 1
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
70 Years
Healthy volunteers
No
Start date
14.11.2024
Completion date
01.12.2026
Registry ID
NCT06680232
Source
anzctr
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