Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruitment ended
Participants planned
28
Countries
1
Sites
2
Allergy to House Dust Mites
Key facts
- Sponsor
- Astellas Pharma Global Development Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 17 Feb 2020 → ongoing
- Decision date (initial)
- 2023-03-21
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2022-500660-35-00
- EudraCT number
- 2018-004678-83
- ClinicalTrials.gov
- NCT04184895
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Allergy to House Dust Mites
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10020419 | House dust mite allergy | 10021428 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Astellas Pharma Global Development Inc.
- Sponsor organisation
- Astellas Pharma Global Development Inc.
- Address
- 2375 Waterview Drive
- City
- Northbrook
- Postcode
- 60062-6145
- Country
- United States
Scientific contact point
- Organisation
- Astellas Pharma Global Development Inc.
- Contact name
- Clinical Trial Unit Head Regulatory Affairs
Public contact point
- Organisation
- Astellas Pharma Global Development Inc.
- Contact name
- Clinical Trial Unit Head Regulatory Affairs
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ongoing, recruitment ended | 28 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
Fraunhofer Institute Of Toxicology And Experimental Medicine
Fraunhofer Institute for Toxicology and Experimental Medicine ITEM Clinical Airway Research, Nikolai-Fuchs-Strasse 1, Gross Buchholz, Hanover
PAREXEL International GmbH
Early Phase Clinical Unit Berlin, Klinikum Westend Haus 31, Spandauer Damm 130, Berlin
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 | 2020-02-17 | 2020-02-17 | 2021-09-22 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-01-23 | Germany | Acceptable 2023-03-20
|
2023-03-21 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-02-26 | Germany | Acceptable 2023-03-20
|
2024-02-26 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-11-27 | Germany | Acceptable 2023-03-20
|
2024-11-27 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-07-29 | Germany | Acceptable 2023-03-20
|
2025-07-29 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2025-11-19 | Germany | Acceptable 2023-03-20
|
2025-11-19 |