Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Authorised, recruitment pending
Participants planned
72
Countries
1
Sites
2
Acute Ischemic Stroke
Key facts
- Sponsor
- Neutrolis Inc.
- Participant type
- Healthy volunteers, Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Decision date (initial)
- 2024-12-02
- 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
Acute Ischemic Stroke
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 22.1 | PT | 10061256 | Ischaemic stroke | 100000004852 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Neutrolis Inc.
- Sponsor organisation
- Neutrolis Inc.
- Address
- 700 Main Street
- City
- Cambridge
- Postcode
- 02139-3543
- Country
- United States
Scientific contact point
- Organisation
- Neutrolis Inc.
- Contact name
- CEO
Public contact point
- Organisation
- Neutrolis Inc.
- Contact name
- CEO
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Authorised, recruitment pending | 72 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-05 | Austria | Acceptable with conditions 2024-11-25
|
2024-12-02 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-01-27 | Austria | Acceptable 2025-03-17
|
2025-03-21 |
| 3 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-05-12 | Austria | Acceptable 2025-07-16
|
2025-07-21 |