Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
30
Countries
1
Sites
1
Anaphylaxis
Key facts
- Sponsor
- Orexo AB
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Not possible to specify
- Trial duration
- 1 Oct 2024 → 12 Dec 2024
- Decision date (initial)
- 2024-09-11
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Anaphylaxis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 23.1 | LLT | 10002218 | Anaphylaxis | 10021428 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Orexo AB
- Sponsor organisation
- Orexo AB
- Address
- Virdings Alle 32 A, Vaksala Vaksala
- City
- Uppsala
- Postcode
- 754 50
- Country
- Sweden
Scientific contact point
- Organisation
- Orexo AB
- Contact name
- Martin Jönsson, Clinical Pharmacologist
Public contact point
- Organisation
- Orexo AB
- Contact name
- Martin Jönsson, Clinical Pharmacologist
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Sweden | Ended | 30 | 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 | 2024-10-01 | 2024-12-12 | 2024-10-01 | 2024-11-21 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-06-28 | Sweden | Acceptable 2024-09-11
|
2024-09-11 |