Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Not authorised
Participants planned
60
Countries
1
Sites
1
Covid-19 Prophylaxis
Key facts
- Sponsor
- Imam Abdulrahman Bin Faisal University
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Virus Diseases [C02]
- Decision date (initial)
- 2023-10-13
- 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
Covid-19 Prophylaxis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 23.0 | PT | 10084458 | COVID-19 prophylaxis | 100000004865 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Imam Abdulrahman Bin Faisal University
- Sponsor organisation
- Imam Abdulrahman Bin Faisal University
- Address
- King Faisal Street
- City
- Dammam
- Postcode
- 31441
- Country
- Saudi Arabia
Scientific contact point
- Organisation
- Imam Abdulrahman Bin Faisal University
- Contact name
- Iman Almansour
Public contact point
- Organisation
- Imam Abdulrahman Bin Faisal University
- Contact name
- Iman Almansour
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Not authorised | 60 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-08-04 | Belgium | Not acceptable 2023-10-12
|
2023-10-13 |