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Clinical Trial Report

Gene Therapy Trial Report

Summary

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

NCTID NCT06680232 (View at clinicaltrials.gov)
Description
Development Status Active
Indication Chronic Hepatitis B
Disease Ontology Term DOID:2043
Compound Name PBGENE-HBV
Sponsor Precision BioSciences, Inc.
Funder Type Industry
Recruitment Status
Recruiting
Enrollment Count 45
Results Posted Not Available

Therapy Information

Target Gene/Variant HBV DNA
Therapy Type Gene editing
Therapy Route In-vivo
Mechanism of Action Gene inactivation
Route of Administration Intravenous
Drug Product Type LNP
Target Tissue/Cell
Delivery System Lipid encapsulation
Vector Type LNP
Editor Type ARCUS
Dose 1 0.25mg/kg
Dose 2 Undisclosed medium/high doses
Dose 3
Dose 4
Dose 5

Study Record Dates

Current Stage Phase1
Submit Date 2024-10-24
Completion Date 2026-12
Last Update 2025-02-10

Participation Criteria

Eligible Age 18 Years - 70 Years
Standard Ages Adult, Older adult
Sexes Eligible for Study ALL

Locations

No.of Trial Sites 3
Locations New Zealand,Hong Kong,Moldova, Republic of

Regulatory Information

Has US IND True
FDA Designations Fast Track
Recent Updates IND cleared by FDA in March 2025

Resources/Links

News and Press Releases
Preclinical Publications