Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
48
Countries
1
Sites
1
Cardiovascular disease
Key facts
- Sponsor
- Cereno Scientific AB
- Participant type
- Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- 24 Jun 2024 → 15 Apr 2025
- Decision date (initial)
- 2024-06-18
- 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
Cardiovascular disease
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Cereno Scientific AB
- Sponsor organisation
- Cereno Scientific AB
- Address
- Pepparedsleden 1, Fassberg Fassberg
- City
- Molndal
- Postcode
- 431 53
- Country
- Sweden
Scientific contact point
- Organisation
- Cereno Scientific AB
- Contact name
- Head of preclinical research
Public contact point
- Organisation
- Cereno Scientific AB
- Contact name
- Head of preclinical research
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Sweden | Ended | 48 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
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 |
|---|---|---|---|---|---|
| Sweden | 2024-06-24 | 2025-04-15 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-04-04 | Sweden | Acceptable 2024-06-13
|
2024-06-18 |