Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
79
Countries
1
Sites
1
autoimmunity
Key facts
- Sponsor
- Immutep
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 17 Jul 2024 → ongoing
- Decision date (initial)
- 2024-07-16
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
autoimmunity
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Immutep
- Sponsor organisation
- Immutep
- Address
- Batiment 7 Le Pythagore Route De L Orme Route Departementale, 128 Parc Des Algorithmes 128 Parc Des Algorithmes
- City
- St Aubin
- Postcode
- 91190
- Country
- France
Scientific contact point
- Organisation
- Immutep
- Contact name
- Principal Investigator, M. Moerland
Public contact point
- Organisation
- Immutep
- Contact name
- Principal Investigator, M. Moerland
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruiting | 79 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Centre for Human Drug Research
Immunology, Zernikedreef 8, 2333 CL, Leiden
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 |
|---|---|---|---|---|---|
| Netherlands | 2024-07-17 | 2024-07-23 |
Application history
8 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-05-27 | Netherlands | Acceptable 2024-07-16
|
2024-07-16 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-07-16 | Netherlands | Acceptable 2024-07-16
|
2024-07-16 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-07-29 | Netherlands | Acceptable 2024-07-16
|
2024-07-29 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2024-08-09 | Netherlands | Acceptable 2024-07-16
|
2024-08-09 |
| 5 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-05-08 | Netherlands | Acceptable 2025-05-15
|
2025-05-15 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2025-07-28 | Netherlands | Acceptable 2025-05-15
|
2025-07-28 |
| 7 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-01-20 | Netherlands | Acceptable 2026-01-28
|
2026-01-29 |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2026-04-29 | Netherlands | Acceptable 2026-01-28
|
2026-04-29 |