NCT06680232

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

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)

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Precision BioSciences, Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HEPATITIS B CHRONIC

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-11-14
• Primary completion: 2025-12-01
• Completion: 2026-12-01
• First posted: 2024-11-08
• Last updated: 2025-09-26

Locations

4 sites across 4 countries: United States, Hong Kong, Moldova, New Zealand

Regulatory

• FDA-regulated drug study