Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
33
Countries
2
Sites
3
Healthy Volunteers
Key facts
- Sponsor
- AstraZeneca AB
- Participant type
- Patients, Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Not possible to specify
- Trial duration
- 11 Nov 2024 → 23 Apr 2025
- Decision date (initial)
- 2024-10-28
- 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
Healthy Volunteers
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10068230 | Cardiorenal syndrome | 100000004849 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
AstraZeneca AB
- Sponsor organisation
- AstraZeneca AB
- Address
- -
- City
- Sodertalje
- Postcode
- 151 85
- Country
- Sweden
Scientific contact point
- Organisation
- AstraZeneca AB
- Contact name
- AstraZeneca Clinical Study Information Centre
Public contact point
- Organisation
- AstraZeneca AB
- Contact name
- AstraZeneca Clinical Study Information Centre
Locations
2 EU/EEA countries · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Bulgaria | Ended | 13 | 2 |
| Romania | Ended | 20 | 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 |
|---|---|---|---|---|---|
| Bulgaria | 2024-11-11 | 2025-04-23 | 2024-11-18 | 2025-04-10 | |
| Romania | 2024-11-14 | 2025-04-23 | 2024-11-20 | 2025-04-10 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-03 | Romania | Acceptable with conditions 2024-10-21
|
2024-10-28 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-11-22 | Romania | Acceptable 2025-02-10
|
2025-02-14 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-03-10 | Romania | Acceptable 2025-02-10
|
2025-03-10 |