Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
52
Countries
1
Sites
1
Atherosclerosis
Key facts
- Sponsor
- Merck Sharp & Dohme LLC
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- 24 Mar 2025 → 3 Apr 2026
- Decision date (initial)
- 2025-03-11
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-520214-22-00
- WHO UTN
- U1111-1316-8163
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Atherosclerosis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 26.0 | LLT | 10003601 | Atherosclerosis | 10047065 |
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
- Julie Fiore
Public contact point
- Organisation
- Merck Sharp & Dohme LLC
- Contact name
- Julie Fiore
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 52 | 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 | 2025-03-24 | 2026-04-02 | 2025-03-25 | 2026-02-25 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-02-04 | Belgium | Acceptable 2025-03-11
|
2025-03-11 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-08-21 | Belgium | Acceptable 2025-09-22
|
2025-09-22 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-10-16 | Belgium | Acceptable 2025-09-22
|
2025-10-16 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-03-04 | Belgium | Acceptable 2025-09-22
|
2026-03-04 |