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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)

Who can join

Ages 18 to 70 · All sexes

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

About the study

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.

What is being tested

• PBGENE-HBV (biological)

Sponsor: Precision BioSciences, Inc. · Participants: 45 · Started: Nov 14, 2024

Contact the study team

• Precision Trial Manager · Phone: 800-371-8953

Official record on ClinicalTrials.gov — NCT06680232

Locations in the U.S.

Conditions

• Hepatitis B

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.