Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
60
Countries
1
Sites
1
Alzheimer's disease
Key facts
- Sponsor
- Immunobrain Checkpoint Ltd.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 31 Oct 2023 → 16 Dec 2025
- Decision date (initial)
- 2024-06-28
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-511770-76-00
- EudraCT number
- 2021-006580-19
- WHO UTN
- U1111-1303-6922
- ClinicalTrials.gov
- NCT05551741
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Alzheimer's disease
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10001896 | Alzheimer's disease | 10029205 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Immunobrain Checkpoint Ltd.
- Sponsor organisation
- Immunobrain Checkpoint Ltd.
- Address
- Weizmann Science Park, 3, Pinhas Sapir Street 3, Pinhas Sapir Street
- City
- Ness Ziona
- Postcode
- 7414002
- Country
- Israel
Scientific contact point
- Organisation
- Immunobrain Checkpoint Ltd.
- Contact name
- Iris Tavor
Public contact point
- Organisation
- Immunobrain Checkpoint Ltd.
- Contact name
- Iris Tavor
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ended | 1 | 1 |
| Rest of world
Israel, United Kingdom
|
— | 59 | — |
Investigational sites
Brain Research Center Amsterdam B.V.
Neurology, Cronenburg 2, 1081 GN, Amsterdam
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 | 2023-10-31 | 2025-10-21 | 2024-01-30 | 2025-01-21 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-06-19 | Netherlands | Acceptable 2024-06-28
|
2024-06-28 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-11-06 | Netherlands | Acceptable 2024-06-28
|
2024-11-06 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-01-28 | Netherlands | Acceptable 2024-06-28
|
2025-01-28 |
| 4 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-04-28 | Netherlands | Acceptable 2025-05-21
|
2025-05-22 |