Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
86
Countries
1
Sites
1
Neuroinflammatory and neurodegenerative diseases
Key facts
- Sponsor
- Ventus Therapeutics U.S. Inc.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 21 Jul 2023 → 17 Apr 2024
- Decision date (initial)
- 2023-07-20
- 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
Neuroinflammatory and neurodegenerative diseases
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Ventus Therapeutics U.S. Inc.
- Sponsor organisation
- Ventus Therapeutics U.S. Inc.
- Address
- 100 Beaver Street Suite 201
- City
- Waltham
- Postcode
- 02453-8400
- Country
- United States
Scientific contact point
- Organisation
- Ventus Therapeutics U.S. Inc.
- Contact name
- Ventus Therapeutics U.S. Inc.
Public contact point
- Organisation
- Ventus Therapeutics U.S. Inc.
- Contact name
- Ventus Therapeutics U.S. Inc.
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ended | 86 | 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 | 2023-07-21 | 2024-04-17 | 2023-08-02 | 2024-04-17 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-06-12 | Netherlands | Acceptable 2023-07-20
|
2023-07-20 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-10-23 | Netherlands | Acceptable 2023-10-31
|
2023-10-31 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2023-11-01 | Netherlands | Acceptable 2023-10-31
|
2023-11-01 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2023-11-14 | Netherlands | Acceptable 2023-10-31
|
2023-11-14 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2024-02-22 | Netherlands | Acceptable 2023-10-31
|
2024-02-22 |
| 6 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-03-04 | Netherlands | Acceptable | 2024-03-13 |