Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
12
Countries
1
Sites
1
grass pollen allergy
Key facts
- Sponsor
- Alk-Abello A/S
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 26 Oct 2023 → 31 Jan 2024
- Decision date (initial)
- 2023-10-19
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-505783-11-00
- WHO UTN
- U1111-1293-8952
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
grass pollen allergy
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Alk-Abello A/S
- Sponsor organisation
- Alk-Abello A/S
- Address
- Boege Alle 6/8
- City
- Hoersholm
- Postcode
- 2970
- Country
- Denmark
Scientific contact point
- Organisation
- Alk-Abello A/S
- Contact name
- ALK-Abelló A/S/ Global Clinical Development
Public contact point
- Organisation
- Alk-Abello A/S
- Contact name
- ALK-Abelló A/S/ Global Clinical Development
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ended | 12 | 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 |
|---|---|---|---|---|---|
| Germany | 2023-10-26 | 2024-01-31 | 2023-11-16 | 2024-01-25 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-08-21 | Germany | Acceptable 2023-10-18
|
2023-10-19 |