Clinical trial • Phase I • Infectious Disease
PBGENE-HBV for Chronic hepatitis B
Phase I trial of PBGENE-HBV for Chronic hepatitis B. adaptive. 22 participants.
Overview
- Trial Therapeutic Area
- Infectious Disease
- Trial Disease
- Chronic hepatitis B
- Trial Stage
- Phase I
Key dates
- Initial CTIS Submission Date
- 26-11-2025
- First CTIS Authorization Date
- 08-04-2026
Trial design
adaptive Phase I trial across 3 sites in France, Romania.
- Adaptive
- True, Dose-escalation: study will use increasing dose amounts to assess safety and tolerability (as described in the public title).
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 22
Recruitment
- Planned Sample Size
- 22
- Recruitment Window Months
- 21
Geography
- Total Number Of Sites
- 3
- Total Number Of Participants
- 20
France
- Earliest CTIS Part Ii Submission Date
- 23-03-2026
- Latest Decision Or Authorization Date
- 08-04-2026
- Processing Time Days
- 16
- Number Of Sites
- 1
- Number Of Participants
- 3
Sites
- Site Name
- Hopital Beaujon
- Department Name
- Hepatology
- Principal Investigator Name
- Tarik Asselah
- Principal Investigator Email
- tarik.asselah@aphp.fr
- Contact Person Name
- Tarik Asselah
- Contact Person Email
- tarik.asselah@aphp.fr
Romania
- Earliest CTIS Part Ii Submission Date
- 09-03-2026
- Latest Decision Or Authorization Date
- 14-04-2026
- Processing Time Days
- 36
- Number Of Sites
- 2
- Number Of Participants
- 17
Sites
- Site Name
- County Clinical Emergency Hospital Cluj-Napoca
- Department Name
- Medical
- Principal Investigator Name
- Vlad Ichim
- Principal Investigator Email
- Vlad.ichim.ext@arensia-em.com
- Contact Person Name
- Vlad Ichim
- Contact Person Email
- Vlad.ichim.ext@arensia-em.com
- Site Name
- National Institute of Infectious Diseases Prof. Dr. Matei Bal
- Department Name
- Infectious Diseases
- Principal Investigator Name
- Anca Streinu-Cercel
- Principal Investigator Email
- anca.streinucercel@gmail.com
- Contact Person Name
- Anca Streinu-Cercel
- Contact Person Email
- anca.streinucercel@gmail.com
Sponsor
Primary sponsor
- Full Name
- Precision Biosciences Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Investigational products
- Investigational Product Name
- PBGENE-HBV
- First In Human
- Yes
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