Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
50
Countries
1
Sites
1
Not applicable, healthy volunteers
Key facts
- Sponsor
- AstraZeneca AB
- Participant type
- Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Not possible to specify
- Trial duration
- 28 May 2025 → 29 Jan 2026
- Decision date (initial)
- 2025-04-25
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-518467-35-00
- ClinicalTrials.gov
- NCT06942936
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Not applicable, healthy volunteers
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 Center
Public contact point
- Organisation
- AstraZeneca AB
- Contact name
- AstraZeneca Clinical Study Information Center
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ended | 32 | 1 |
| Rest of world
United States
|
— | 18 | — |
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 |
|---|---|---|---|---|---|
| Germany | 2025-05-28 | 2026-01-28 | 2025-05-28 | 2025-11-06 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-02-21 | Germany | Acceptable with conditions 2025-04-23
|
2025-04-25 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-05-05 | Germany | Acceptable 2025-05-22
|
2025-05-22 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-07-10 | Germany | Acceptable 2025-08-18
|
2025-08-20 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-08-25 | Germany | Acceptable | 2025-09-08 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-12-19 | Germany | Acceptable 2026-01-16
|
2026-01-19 |