Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
56
Countries
1
Sites
1
Diabetic Retinopathy
Key facts
- Sponsor
- Breye Therapeutics ApS
- Participant type
- Patients, Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Eye Diseases [C11], Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Trial duration
- 16 Apr 2025 → 27 Oct 2025
- Decision date (initial)
- 2025-03-14
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Diabetic Retinopathy
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 27.1 | PT | 10012689 | Diabetic retinopathy | 100000004853 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Breye Therapeutics ApS
- Sponsor organisation
- Breye Therapeutics ApS
- Address
- Agern Alle 24
- City
- Hoersholm
- Postcode
- 2970
- Country
- Denmark
Scientific contact point
- Organisation
- Breye Therapeutics ApS
- Contact name
- CEO
Public contact point
- Organisation
- Breye Therapeutics ApS
- Contact name
- CEO
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Sweden | Ended | 56 | 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 | 2025-04-16 | 2025-10-27 | 2025-04-16 | 2025-10-27 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-12-12 | Sweden | Acceptable with conditions 2025-03-14
|
2025-03-14 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-06-25 | Sweden | Acceptable 2025-07-22
|
2025-08-11 |