Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
54
Countries
1
Sites
3
Human Papilloma virus
Key facts
- Sponsor
- Merck Sharp & Dohme LLC
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Virus Diseases [C02]
- Trial duration
- 27 May 2025 → ongoing
- Decision date (initial)
- 2025-01-08
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-518863-36-00
- WHO UTN
- U1111-1314-3100
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Human Papilloma virus
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 27.1 | LLT | 10063001 | Human papilloma virus infection | 10021881 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Merck Sharp & Dohme LLC
- Sponsor organisation
- Merck Sharp & Dohme LLC
- Address
- 126 East Lincoln Avenue, P. O. Box 2000 P. O. Box 2000
- City
- Rahway
- Postcode
- 07065-4607
- Country
- United States
Scientific contact point
- Organisation
- Merck Sharp & Dohme LLC
- Contact name
- David Alexanderian
Public contact point
- Organisation
- Merck Sharp & Dohme LLC
- Contact name
- David Alexanderian
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruiting | 54 | 3 |
| 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 | 2025-05-27 | 2025-06-16 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-11-15 | Belgium | Acceptable 2025-01-08
|
2025-01-08 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-04-10 | Belgium | Acceptable 2025-05-08
|
2025-05-08 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-09-08 | Belgium | Acceptable 2025-09-19
|
2025-09-22 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2026-04-27 | Belgium | Acceptable 2026-05-29
|
2026-05-29 |