Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
65
Countries
1
Sites
1
Healthy volunteers [targeted indication: chronic obstructive pulmonary disease (COPD)]
Key facts
- Sponsor
- 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
- 20 Feb 2025 → 18 Nov 2025
- Decision date (initial)
- 2024-11-15
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-516187-29-00
- WHO UTN
- U1111-1310-4490
- ClinicalTrials.gov
- NCT06677918
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Healthy volunteers [targeted indication: chronic obstructive pulmonary disease (COPD)]
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 26.1 | 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
- Reykjavik
- Postcode
- 102
- Country
- Iceland
Scientific contact point
- Organisation
- EpiEndo Pharmaceuticals ehf.
- Contact name
- Sponsor Clinical Trial Information
Public contact point
- Organisation
- EpiEndo Pharmaceuticals ehf.
- Contact name
- Sponsor Clinical Trial Information
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ended | 65 | 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 | 2025-02-20 | 2025-11-18 | 2025-02-20 | 2025-10-15 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-20 | Germany | Acceptable 2024-11-14
|
2024-11-15 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-02-26 | Germany | Acceptable 2024-11-14
|
2025-02-26 |