Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
16
Countries
1
Sites
1
Influenza virus
Key facts
- Sponsor
- Eradivir Inc.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Virus Diseases [C02]
- Trial duration
- 10 Jul 2025 → 23 Sep 2025
- Decision date (initial)
- 2025-07-03
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Influenza virus
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Eradivir Inc.
- Sponsor organisation
- Eradivir Inc.
- Address
- 1209 North Orange Street
- City
- Wilmington
- Postcode
- 19801-1120
- Country
- United States
Scientific contact point
- Organisation
- Eradivir Inc.
- Contact name
- -
Public contact point
- Organisation
- Eradivir Inc.
- Contact name
- -
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | 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 | 2025-07-10 | 2025-07-10 | 2025-07-28 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 1 · Art. 38 CTR
Temporary halt TH-93129
- Halt date
- 2025-07-28
- Member states concerned
- Belgium
- Publication date
- 2025-08-04
- Reason
- Safety related (clinical or pre-clinical results)
- Explanation
- An internal investigation has been launched to better understand the origin of these unexpected adverse events.
- Follow-up measures
- Subjects dosed will continue with trial conduct and safety is being monitored and documented.
Subjects that were not dosed were sent home. - Benefit-risk balance changed
- Yes
- Treatment stopped
- Yes
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-05-23 | Belgium | Acceptable 2025-07-03
|
2025-07-03 |