Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
144
Countries
1
Sites
1
Influenza
Key facts
- Sponsor
- Sumitomo Pharma Co. Ltd.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Virus Diseases [C02]
- Trial duration
- 26 Jun 2024 → 1 Apr 2026
- Decision date (initial)
- 2024-05-03
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-504378-39-00
- ClinicalTrials.gov
- NCT06460064
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Influenza
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10022000 | Influenza | 100000004862 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Sumitomo Pharma Co. Ltd.
- Sponsor organisation
- Sumitomo Pharma Co. Ltd.
- Address
- 6-8 Doshomachi 2 Chome, Chuo Ku Chuo Ku
- City
- Osaka
- Postcode
- 541-0045
- Country
- Japan
Scientific contact point
- Organisation
- Sumitomo Pharma Co. Ltd.
- Contact name
- Clinical trial information desk
Public contact point
- Organisation
- Sumitomo Pharma Co. Ltd.
- Contact name
- Product information center
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 144 | 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 | 2024-06-26 | 2026-03-31 | 2024-06-26 | 2025-04-28 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-03-21 | Belgium | Acceptable with conditions 2024-05-03
|
2024-05-03 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-11-15 | Belgium | Acceptable 2024-11-29
|
2024-11-29 |