Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
112
Countries
1
Sites
1
Obesity / Right heart failure (healthy participants)
Key facts
- Sponsor
- Corteria Pharmaceuticals
- Participant type
- Healthy volunteers, Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14], Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Trial duration
- 10 Sep 2024 → ongoing
- Decision date (initial)
- 2024-09-04
- 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
Obesity / Right heart failure (healthy participants)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10029883 | Obesity | 100000004861 |
| 26.0 | LLT | 10088820 | Clinical trial healthy volunteer | 100000004848 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Corteria Pharmaceuticals
- Sponsor organisation
- Corteria Pharmaceuticals
- Address
- 128 Rue La Boetie
- City
- Paris
- Postcode
- 75008
- Country
- France
Scientific contact point
- Organisation
- Corteria Pharmaceuticals
- Contact name
- Philip Janiak
Public contact point
- Organisation
- Corteria Pharmaceuticals
- Contact name
- Philip Janiak
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ongoing, recruiting | 112 | 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 | 2024-09-10 | 2024-09-10 |
Application history
7 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-06-21 | Germany | Acceptable 2024-08-15
|
2024-09-04 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-12-27 | Germany | Acceptable 2025-03-05
|
2025-03-06 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-04-04 | Germany | Acceptable 2025-05-13
|
2025-05-14 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-10-10 | Germany | Acceptable 2025-10-29
|
2025-11-12 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2026-01-16 | Germany | Acceptable 2026-02-04
|
2026-02-12 |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2026-03-13 | Germany | Acceptable 2026-04-27
|
2026-04-28 |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-05-05 | Germany | Acceptable 2026-04-27
|
2026-05-05 |