Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
64
Countries
1
Sites
1
Neurodegenerative disorders
Key facts
- Sponsor
- Cerevance Inc.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 15 Aug 2023 → 20 Jun 2024
- Decision date (initial)
- 2023-08-15
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Neurodegenerative disorders
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Cerevance Inc.
- Sponsor organisation
- Cerevance Inc.
- Address
- 1 Marina Park Drive Ste 1410
- City
- Boston
- Postcode
- 02210-1874
- Country
- United States
Scientific contact point
- Organisation
- Cerevance Inc.
- Contact name
- Principal Investigator CHDR
Public contact point
- Organisation
- Cerevance Inc.
- Contact name
- Principal Investigator CHDR
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ended | 64 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Centre for Human Drug Research
NA, 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 | 2023-08-15 | 2024-06-20 | 2023-08-25 | 2024-06-20 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-07-03 | Netherlands | Acceptable 2023-08-15
|
2023-08-15 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2023-10-11 | Netherlands | Acceptable 2023-08-15
|
2023-10-11 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-10-30 | Netherlands | Acceptable 2023-11-06
|
2023-11-06 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-03-27 | Netherlands | Acceptable 2024-04-15
|
2024-04-15 |