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NCT Number: NCT06680232

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

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Queen Mary Hospital, The University of Hong Kong, Hong Kong

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About this study

Refer to key Inclusion and Exclusion criteria.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PBGENE-HBV

Biological

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.

Primary outcomes

  1. Safety to Assess Treatment-emergent Adverse Events (TEAEs)

    Time frame: 4 weeks after final dose

    Frequency of TEAEs

Secondary outcomes

  1. 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)

  2. Pharmacokinetics of AUC

    Time frame: 4 weeks

    Total PBGENE-HBV exposure over time

  3. Pharmacokinetics of Cmax

    Time frame: 4 weeks

    Time at which Cmax (maximum peak concentration of PBGENE-HBV) is observed

  4. Pharmacokinetics of Cmin

    Time frame: 4 weeks

    Minimum (or trough) concentration of PBGENE-HBV

  5. Pharmacokinetics of half life (t1/2)

    Time frame: 4 weeks

    Terminal half life

  6. Antiviral Activity of HBsAg and Anti-HBs

    Time frame: 48 weeks

    Changes from baseline in hepatitis B surface antigen (HBsAg) and anti-HBs levels

  7. Antiviral Activity of HBV DNA

    Time frame: 48 weeks

    Changes from baseline of HBV DNA

Study contacts

Contact information is provided by the study sponsor or research team.

Precision Trial Manager

CONTACT

[email protected]

800-371-8953

Sponsors and collaborators

Lead sponsor

Precision BioSciences, Inc.

Industry

Registry information

Official study title

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)

Acronym: ELIMINATE-B

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Nov 8, 2024
Registry last updated
Sep 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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