Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
14
Countries
1
Sites
1
Crohn's Disease
Key facts
- Sponsor
- Astrazeneca AB
- Participant type
- Patients, Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Digestive System Diseases [C06]
- Trial duration
- 25 Sep 2023 → 8 Oct 2024
- Decision date (initial)
- 2023-08-31
- 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
Crohn's Disease
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Astrazeneca AB
- Sponsor organisation
- Astrazeneca AB
- Address
- Astraallen Gartuna, Karlebyhus Byggnad 674 Karlebyhus Byggnad 674
- 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 |
|---|---|---|---|
| Sweden | Ended | 14 | 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 | 2023-09-25 | 2024-10-08 | 2023-09-25 | 2024-08-21 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-06-14 | Sweden | Acceptable 2023-08-30
|
2023-08-31 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-02-26 | Sweden | Acceptable 2024-04-03
|
2024-04-09 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-05-22 | Sweden | Acceptable 2024-04-03
|
2024-05-22 |