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

September 22, 2025 updated by: Precision BioSciences, Inc.

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)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Refer to key Inclusion and Exclusion criteria.

Study Type

Interventional

Enrollment (Estimated)

45

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Hong Kong
    • Hong Kong
      • Hong Kong, Hong Kong, Hong Kong
        • Recruiting
        • Queen Mary Hospital, The University of Hong Kong
        • Contact:
          • Man-Fung Yuen, MBBS, MD, PhD, DSc
          • Phone Number: 852-2255 3579
          • Email: mfyuen@hku.hk
  • Moldova
      • Chisinau, Moldova, 2025
        • Recruiting
        • ICS ARENSIA Exploratory Medicine SRL
        • Contact:
  • New Zealand
      • Auckland, New Zealand, 1010
        • Recruiting
        • New Zealand Clinical Research
        • Contact:
        • Contact:
  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital/Harvard University
        • Contact:
        • Principal Investigator:
          • Raymond T Chung, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Participants in both Part 1 and 2 will receive a finite course of PBGENE-HBV.
All participants will receive a finite course of multiple IV dose administrations of PBGENE-HBV. In Part 1, this will be done in a dose escalation manner which may be evaluated further in a Part 2 expansion cohort.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety to Assess Treatment-emergent Adverse Events (TEAEs)
Time Frame: 4 weeks after final dose
Frequency of TEAEs
4 weeks after final dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Additional Safety
Time Frame: 48 weeks
Frequency and severity of adverse events and changes in physical examinations, vital signs, and safety labs (hematology, chemistry, and urinalysis)
48 weeks
Pharmacokinetics of AUC
Time Frame: 4 weeks
Total PBGENE-HBV exposure over time
4 weeks
Pharmacokinetics of Cmax
Time Frame: 4 weeks
Time at which Cmax (maximum peak concentration of PBGENE-HBV) is observed
4 weeks
Pharmacokinetics of Cmin
Time Frame: 4 weeks
Minimum (or trough) concentration of PBGENE-HBV
4 weeks
Pharmacokinetics of half life (t1/2)
Time Frame: 4 weeks
Terminal half life
4 weeks
Antiviral Activity of HBsAg and Anti-HBs
Time Frame: 48 weeks
Changes from baseline in hepatitis B surface antigen (HBsAg) and anti-HBs levels
48 weeks
Antiviral Activity of HBV DNA
Time Frame: 48 weeks
Changes from baseline of HBV DNA
48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Precision BioSciences, Inc.

Investigators

  • Study Director: Stanley Frankel, MD Medical Monitor, Precision BioSciences, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 14, 2024

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

October 24, 2024

First Submitted That Met QC Criteria

November 6, 2024

First Posted (Actual)

November 8, 2024

Study Record Updates

Last Update Posted (Estimated)

September 26, 2025

Last Update Submitted That Met QC Criteria

September 22, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PBGENE-HBV-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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