Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
28
Countries
1
Sites
6
Asthma
Key facts
- Sponsor
- AstraZeneca AB
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Respiratory Tract Diseases [C08]
- Trial duration
- 19 Feb 2025 → 29 May 2025
- Decision date (initial)
- 2024-11-21
- 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
Asthma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10003553 | Asthma | 100000004855 |
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
- Clinical Study Information Centre
Public contact point
- Organisation
- AstraZeneca AB
- Contact name
- Clinical Study Information Centre
Locations
1 EU/EEA country · 6 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ended | 16 | 6 |
| Rest of world
United Kingdom
|
— | 12 | — |
Investigational sites
Velocity Clinical Research GmBH
#2606, Ansbacher Strasse 17-19, Schoeneberg, Berlin
IKF Pneumologie GmbH & Co. KG
#2604, Stresemannallee 3, Sachsenhausen, Frankfurt Am Main
The Fraunhofer Institute For Toxicology And Experimental Medicine ITEM
#2605:Clinical Airway Research, Nikolai-Fuchs-Strasse 1, Gross Buchholz, Hanover
Studienpraxis Berlin-Brandenburg Cornelia Seelbinder Und Lennart Schaper GbR
#2603, Torstrasse 117, Mitte, Berlin
Velocity Clinical Research Germany GmbH
#2601, Sandstrasse 18, Innenstadt, Luebeck
Velocity Clinical Research Germany GmbH
#2602, Klaus-Groth-Strasse 2-4, 22926, Ahrensburg
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 | 2025-02-19 | 2025-05-09 | 2025-03-10 | 2025-03-25 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-27 | Germany | Acceptable 2024-11-05
|
2024-11-21 |