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

Last updated: February 6, 2025
Sponsor: Precision BioSciences, Inc.
Overall Status: Active - Recruiting

Phase

1

Condition

Hepatitis

Liver Disorders

Hepatitis B

Treatment

PBGENE-HBV

Clinical Study ID

NCT06680232
PBGENE-HBV-01
  • Ages 18-70
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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

Exclusion

Key Exclusion Criteria:

  • No history of cirrhosis of the liver

  • No current infections of Hepatitis A, D, and E, human immunodeficiency virus (type 1and 2), and no history of or current hepatitis C. In addition, no other activeinfections 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 arecured by surgical resection (e.g., basal cell skin cancer)

  • No investigational agent received within 6 months of screening

Study Design

Total Participants: 45
Treatment Group(s): 1
Primary Treatment: PBGENE-HBV
Phase: 1
Study Start date:
November 14, 2024
Estimated Completion Date:
December 31, 2026

Study Description

Refer to key Inclusion and Exclusion criteria.

Connect with a study center

  • Queen Mary Hospital, The University of Hong Kong

    Pok Fu Lam,
    Hong Kong

    Active - Recruiting

  • ICS ARENSIA Exploratory Medicine SRL

    Chisinau, 2025
    Moldova, Republic of

    Active - Recruiting

  • New Zealand Clinical Research

    Auckland, 1010
    New Zealand

    Active - Recruiting

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