Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
67
Countries
3
Sites
5
Chronic hepatitis B virus Infection
Key facts
- Sponsor
- Arbutus Biopharma Inc.
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Virus Diseases [C02]
- Trial duration
- 13 Dec 2024 → 26 Nov 2025
- Decision date (initial)
- 2024-12-09
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-508312-39-00
- ClinicalTrials.gov
- NCT05960240
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Chronic hepatitis B virus Infection
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.1 | PT | 10008910 | Chronic hepatitis B | 100000004862 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Arbutus Biopharma Inc.
- Sponsor organisation
- Arbutus Biopharma Inc.
- Address
- 701 Veterans Circle
- City
- Warminster
- Postcode
- 18974-3531
- Country
- United States
Scientific contact point
- Organisation
- Arbutus Biopharma Inc.
- Contact name
- Tilly Varughese
Public contact point
- Organisation
- Arbutus Biopharma Inc.
- Contact name
- Varun Sharma
Locations
3 EU/EEA countries · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Bulgaria | Ended | 10 | 2 |
| Italy | Ended | 7 | 2 |
| Romania | Ended | 10 | 1 |
| Rest of world
Hong Kong, Ukraine, New Zealand, Moldova, Republic of, Singapore
|
— | 40 | — |
Investigational sites
Umbal - Prof. D-R Stoyan Kirkovich AD
Department of Gastroenterology, Ulitsa General Stoletov 2, 6003, Stara Zagora
Military Medical Academy
Clinic of Gastroenterology, Ulitsa Sveti Georgi Sofiyski 3, 1606, Sofiya
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 |
|---|---|---|---|---|---|
| Bulgaria | 2024-12-17 | 2025-09-12 | 2025-01-21 | 2025-05-13 | |
| Italy | 2025-02-21 | 2025-11-25 | 2025-03-04 | 2025-05-13 | |
| Romania | 2024-12-13 | 2025-11-18 | 2024-12-18 | 2025-05-13 |
Application history
7 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-07 | Italy | Acceptable 2024-12-02
|
2024-12-04 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-01-16 | Italy | Acceptable 2024-12-02
|
2025-01-16 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-02-12 | Italy | Acceptable | 2025-03-18 |
| 4 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-02-13 | Acceptable | 2025-03-24 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-02-13 | Acceptable | 2025-04-02 | |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-08-20 | Italy | Acceptable | 2025-08-20 |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-08-27 | Italy | Acceptable | 2025-08-27 |