Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruitment ended
Participants planned
16
Countries
1
Sites
1
Hepatitis B
Key facts
- Sponsor
- AstriVax
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Virus Diseases [C02]
- Trial duration
- 6 May 2025 → ongoing
- Decision date (initial)
- 2025-04-28
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Hepatitis B
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.1 | PT | 10008910 | Chronic hepatitis B | 100000004862 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
AstriVax
- Sponsor organisation
- AstriVax
- Address
- Gaston Geenslaan 3 Box 4
- City
- Leuven
- Postcode
- 3001
- Country
- Belgium
Scientific contact point
- Organisation
- AstriVax
- Contact name
- Mathieu Peeters
Public contact point
- Organisation
- AstriVax
- Contact name
- Hanne Callewaert
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruitment ended | 16 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
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 |
|---|---|---|---|---|---|
| Belgium | 2025-05-06 | 2025-05-06 | 2025-06-04 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-02-25 | Belgium | Acceptable 2025-04-28
|
2025-04-28 |