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RecruitingPhase 1

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

Precision BioSciences, Inc. · NCT06680232

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–70 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 1
Target enrollment
45
US sites recruiting
1
Study start
November 14, 2024
Record last updated
August 24, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: PBGENE-HBV

Conditions: HEPATITIS B CHRONIC

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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

Recruiting US locations

  • Massachusetts General Hospital/Harvard University

    Boston, MA 02114

    Site contact: Raymond T Chung, MD · 617-724-75 · Chung.Raymond@mgh.harvard.edu

Study contacts (from the official record)

  • Precision Trial Manager · 800-371-8953 · ELIMINATE-B@precisionbiosciences.com
All phase 1 studies in Massachusetts →
Phase 1 Study to Evaluate Safety and Antiviral Activity of… (NCT06680232) | Bored Studies