Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
32
Countries
1
Sites
2
Respiratory syncytial virus infection
Key facts
- Sponsor
- Merck Sharp & Dohme LLC
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male
- Therapeutic area
- Diseases [C] - Virus Diseases [C02]
- Trial duration
- 30 Mar 2023 → 16 Mar 2024
- Decision date (initial)
- 2023-03-13
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2022-502926-42-00
- WHO UTN
- U1111-1285-8277
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Respiratory syncytial virus infection
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10061603 | Respiratory syncytial virus infection | 100000004862 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Merck Sharp & Dohme LLC
- Sponsor organisation
- Merck Sharp & Dohme LLC
- Address
- 126 East Lincoln Avenue
- City
- Rahway
- Postcode
- 07065-4607
- Country
- United States
Scientific contact point
- Organisation
- Merck Sharp & Dohme LLC
- Contact name
- Kelly Devereaux
Public contact point
- Organisation
- Merck Sharp & Dohme LLC
- Contact name
- Kelly Devereaux
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 32 | 2 |
| 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 | 2023-03-30 | 2024-03-15 | 2023-03-31 | 2024-03-11 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-01-30 | Belgium | Acceptable 2023-03-13
|
2023-03-13 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-03-14 | Belgium | Acceptable | 2023-03-30 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2023-06-21 | Belgium | Acceptable 2023-07-05
|
2023-07-17 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2023-11-03 | Belgium | Acceptable 2023-12-13
|
2023-12-14 |