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RECRUITINGPhase 1INTERVENTIONAL

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

A Phase 1, Open-Label, First-in-Human, Dose Escalation (Part 1) and Expansion (Part 2) Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of PBGENE-HBV in Participants With Chronic Hepatitis B (ELIMINATE-B)

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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 May Be Eligible (Plain English)

Key Who May Qualify: - 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 Who Should NOT Join This Trial: - No history of cirrhosis of the liver - No current infections of Hepatitis A, D, and E, human weakened immune system 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

BIOLOGICAL

PBGENE-HBV

PBGENE-HBV is an in vivo gene editing intervention based on a novel proprietary ARCUS® platform designed to potentially cure chronic hepatitis B virus (HBV) by eliminating cccDNA, the key source of replicating hepatitis B virus, while also inactivating integrated HBV DNA in hepatocytes.

Locations (4)

Massachusetts General Hospital/Harvard University
Boston, Massachusetts, United States
Queen Mary Hospital, The University of Hong Kong
Hong Kong, Hong Kong, Hong Kong
ICS ARENSIA Exploratory Medicine SRL
Chisinau, Moldova
New Zealand Clinical Research
Auckland, New Zealand