A first in human study of people with chronic hepatitis B, where all participants will receive the new drug PBGENE-HBV. This study will use increasing dose amounts of the drug to see how safe and bearable it is. The study will also test how well PBGENE-HBV works and how it is processed by the body.

Start 28 Apr 2026 · Status Authorised, recruiting · 2 EU/EEA countries · 3 sites · Protocol PBGENE-HBV-01

Overview

Sponsor-declared trial summary

Phase Human pharmacology (Phase I) - First administration to humans

Status Authorised, recruiting

Participants planned 42

Countries 2

Sites 3

Chronic Hepatitis B

Key facts

Sponsor: Precision Biosciences Inc.
Participant type: Patients
Age range: 18-64 years, 65+ years
Gender: Male and Female
Therapeutic area: Diseases [C] - Virus Diseases [C02]
Trial duration: 28 Apr 2026 → ongoing
Decision date (initial): 2026-04-08
Transition trial: No
Low-intervention: No
Rare-disease indication: No
Vulnerable population: No

External identifiers

EU CT number: 2025-524157-13-00
ClinicalTrials.gov: NCT06680232

Trial design

CTIS Part I — objectives, methods, condition coding

Conditions and MedDRA coding

Chronic Hepatitis B

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Precision Biosciences Inc.

Sponsor organisation: Precision Biosciences Inc.
Address: 302 East Pettigrew Street Suite A
City: Durham
Postcode: 27701-3712
Country: United States

Scientific contact point

Organisation: Precision Biosciences Inc.
Contact name: Stanley R Frankel

Public contact point

Organisation: Precision Biosciences Inc.
Contact name: Lauren Barclay Loughhead

Locations

2 EU/EEA countries · 3 investigational sites

By country

Country	MS status	Planned subjects	Sites
France	Authorised, recruitment pending	3	1
Romania	Ongoing, recruiting	17	2
Rest of world United Kingdom, United States, New Zealand, Moldova, Republic of, Hong Kong	—	22	—

Investigational sites

France

1 site · Authorised, recruitment pending

Hopital Beaujon

Hepatology, 100 Boulevard Du General Leclerc, 92110, Clichy

Romania

2 sites · Ongoing, recruiting

National Institute of Infectious Diseases Prof. Dr. Matei Bal

Infectious Diseases, 1 Dr. Calistrat Grozovici Street, 021105, Bucharest

County Clinical Emergency Hospital Cluj-Napoca

Medical, 3-5 Clinicilor, 400006, Cluj-Napoca

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country	Trial start	Trial end	Recruitment start	Recruitment end	Early termination
Romania	2026-04-28		2026-05-04

Application history

1 submissions — initial application plus substantial / non-substantial modifications

#	Type	Code	Submitted	Reference MS	Conclusion	Decision date
1	INITIAL	IN	2025-11-26	France	Acceptable 2026-04-07	2026-04-08