Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
99
Countries
1
Sites
1
Rheumatoid Arthritis
Key facts
- Sponsor
- AstraZeneca AB
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 10 Apr 2024 → 13 Jan 2026
- Decision date (initial)
- 2024-04-04
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-509574-34-00
- ClinicalTrials.gov
- NCT06103877
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Rheumatoid Arthritis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 23.1 | PT | 10039073 | Rheumatoid arthritis | 100000004859 |
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 | 29 | 1 |
| Rest of world
United States
|
— | 70 | — |
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 | 2024-04-10 | 2025-07-16 | 2024-04-23 | 2024-11-20 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-01-09 | Germany | Acceptable 2024-04-04
|
2024-04-04 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-04-22 | Germany | Acceptable | 2024-05-17 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-12-09 | Germany | Acceptable 2025-01-16
|
2025-01-31 |