Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruiting
Participants planned
10
Countries
1
Sites
1
Critical limb ischemia
Key facts
- Sponsor
- Aplagon Oy
- Participant type
- Healthy volunteers, Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- 1 Feb 2024 → ongoing
- Decision date (initial)
- 2023-09-07
- 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
Critical limb ischemia
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10058072 | Critical limb ischaemia | 10047065 |
| 21.1 | PT | 10062585 | Peripheral arterial occlusive disease | 100000004866 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Aplagon Oy
- Sponsor organisation
- Aplagon Oy
- Address
- Tukholmankatu 8 A
- City
- Helsinki
- Postcode
- 00290
- Country
- Finland
Scientific contact point
- Organisation
- Aplagon Oy
- Contact name
- Riitta Lassila
Public contact point
- Organisation
- Aplagon Oy
- Contact name
- Aki Prihti
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruiting | 10 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
University Medical Center Groningen
Department of Surgery / Nuclear Medicine and Molecular Imaging, Hanzeplein 1, 9713 GZ, Groningen
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 | 2024-02-01 | 2024-02-02 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-06-30 | Netherlands | Acceptable with conditions 2023-09-07
|
2023-09-07 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-03-11 | Netherlands | Acceptable 2024-04-08
|
2024-04-08 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-06-28 | Netherlands | Acceptable 2024-08-09
|
2024-08-09 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-12-04 | Netherlands | Acceptable 2024-12-17
|
2024-12-17 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-06-06 | Netherlands | Acceptable 2025-07-14
|
2025-07-14 |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2026-01-30 | Netherlands | Acceptable 2026-02-27
|
2026-02-27 |