Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
36
Countries
1
Sites
1
Chronic obstructive pulmonary disease (COPD)
Key facts
- Sponsor
- Epiendo Pharmaceuticals ehf., Epiendo Pharmaceuticals ehf.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Respiratory Tract Diseases [C08]
- Trial duration
- 23 Oct 2023 → 2 Jan 2024
- Decision date (initial)
- 2023-09-26
- 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
Chronic obstructive pulmonary disease (COPD)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10009033 | Chronic obstructive pulmonary disease | 100000004855 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Epiendo Pharmaceuticals ehf.
- Sponsor organisation
- Epiendo Pharmaceuticals ehf.
- Address
- Bjargargata 1
- City
- Reykjavík
- Postcode
- 102
- Country
- Iceland
Scientific contact point
- Organisation
- Epiendo Pharmaceuticals ehf.
- Contact name
- Kate Hanrott
Public contact point
- Organisation
- Epiendo Pharmaceuticals ehf.
- Contact name
- Kate Hanrott
Epiendo Pharmaceuticals ehf.
- Sponsor organisation
- Epiendo Pharmaceuticals ehf.
- Address
- Bjargargata 1
- City
- Reykjavík
- Postcode
- 102
- Country
- Iceland
Scientific contact point
- Organisation
- Epiendo Pharmaceuticals ehf.
- Contact name
- Kate Hanrott
Public contact point
- Organisation
- Epiendo Pharmaceuticals ehf.
- Contact name
- Kate Hanrott
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Sweden | Ended | 36 | 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 | 2023-10-23 | 2024-01-02 | 2023-10-23 | 2024-01-02 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-07-06 | Sweden | Acceptable 2023-09-25
|
2023-09-26 |