Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
142
Countries
1
Sites
1
Atrial Fibrillation (cardiac arrhythmia)
Key facts
- Sponsor
- Acesion Pharma ApS
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- 4 Oct 2023 → 14 Mar 2025
- Decision date (initial)
- 2023-08-28
- 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
Atrial Fibrillation (cardiac arrhythmia)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10003658 | Atrial fibrillation | 100000004849 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Acesion Pharma ApS
- Sponsor organisation
- Acesion Pharma ApS
- Address
- Ole Maaloees Vej 3
- City
- Copenhagen N
- Postcode
- 2200
- Country
- Denmark
Scientific contact point
- Organisation
- Acesion Pharma ApS
- Contact name
- Anders Gaarsdal Holst
Public contact point
- Organisation
- Acesion Pharma ApS
- Contact name
- Birgitte Vestbjerg
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ended | 142 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Pharmaceutical Research Associates Group B.V.
Program Management, Van Swietenlaan 6, 9728 NZ, 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 | 2023-10-04 | 2025-03-14 | 2023-10-04 | 2025-01-31 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-07-17 | Netherlands | Acceptable 2023-08-28
|
2023-08-28 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2023-11-21 | Netherlands | Acceptable 2023-08-28
|
2023-11-21 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-01-15 | Netherlands | Acceptable 2023-08-28
|
2024-01-15 |
| 4 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-03-01 | Netherlands | Acceptable 2024-03-08
|
2024-03-08 |
| 5 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-11-08 | Netherlands | Acceptable 2024-12-13
|
2024-12-13 |