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)

Precision BioSciences, Inc.4 sites in 4 countries45 target enrollmentNovember 14, 2024

ConditionsHEPATITIS B CHRONIC

InterventionsPBGENE-HBV

DrugsPBGENE-HBV

Overview

Phase: Phase 1
Intervention: PBGENE-HBV
Conditions: HEPATITIS B CHRONIC
Sponsor: Precision BioSciences, Inc.
Enrollment: 45
Locations: 4
Primary Endpoint: Safety to Assess Treatment-emergent Adverse Events (TEAEs)
Status: Recruiting
Last Updated: 7 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Detailed Description

Refer to key Inclusion and Exclusion criteria.

Registry

clinicaltrials.gov

Start Date

November 14, 2024

End Date

December 1, 2026

Last Updated

7 months ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Precision BioSciences, Inc.

Responsible Party

Sponsor

Eligibility Criteria

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 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

Arms & Interventions

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.

Intervention: PBGENE-HBV