Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
58
Countries
11
Sites
16
C3 glomerulopathy (C3G)
Key facts
- Sponsor
- Eleva GmbH
- Participant type
- Patients, Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 11 Jun 2025 → ongoing
- Decision date (initial)
- 2025-06-02
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
C3 glomerulopathy (C3G)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10077827 | C3 glomerulopathy | 100000004857 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Eleva GmbH
- Sponsor organisation
- Eleva GmbH
- Address
- Hans-Bunte-Strasse 19, Bruehl Bruehl
- City
- Freiburg Im Breisgau
- Postcode
- 79108
- Country
- Germany
Scientific contact point
- Organisation
- Eleva GmbH
- Contact name
- Dr. Andreas Schaaf
Public contact point
- Organisation
- Eleva GmbH
- Contact name
- Fabienne Zeitter
Locations
11 EU/EEA countries · 16 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ongoing, recruiting | 23 | 1 |
| Belgium | Ongoing, recruiting | 2 | 1 |
| Czechia | Authorised, recruiting | 5 | 1 |
| France | Ongoing, recruiting | 5 | 2 |
| Greece | Ongoing, recruiting | 1 | 1 |
| Latvia | Authorised, recruiting | 5 | 1 |
| Lithuania | Ongoing, recruiting | 5 | 1 |
| Netherlands | Ongoing, recruiting | 2 | 1 |
| Portugal | Ongoing, recruiting | 1 | 1 |
| Spain | Ongoing, recruiting | 7 | 5 |
| Sweden | Ongoing, recruiting | 2 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Medical University Of Vienna
Universitätsklinik für Klinische Pharmakologie, Waehringer Guertel 18-20, Alsergrund, Vienna
Cliniques universitaires Saint-Luc
Rare Kidney Disease Clinic, Avenue Hippocrate 10, 1200, Brussels
Hôpital Européen Georges-Pompidou HEGP
Service de Néphrologie et Hémodialyse, 20 rue Leblanc, 75015, Paris
Centre Hospitalier Universitaire De Toulouse
Service de Néphrologie et Transplantation d’Organes, 1 Avenue Du Professeur Jean Poulhes, Tsa 50032, Toulouse Cedex 9
Laiko General Hospital Of Athens
Clinic of Nephrology and Renal Transplantation, Agiou Thoma (goudi) 17, 115 27, Athens
Vilnius University Hospital Santaros Klinikos
Nephrology, Nephrology center (Corps D, 1 Floor), Vilnius
Amsterdam UMC Stichting
Department of Internal Medicine and Pediatrics, Meibergdreef 9, 1105 AZ, Amsterdam
Hospital Curry Cabral_Centro Hospitalar de Lisboa Central - ULS Sao José
Nephrology, Rua da Beneficência, nº8, Lisboa
University Hospital Virgen Del Rocio S.L.
Department of Nephrology, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital Universitario 12 De Octubre
Nephrology, Avenida De Cordoba Sn, 28041, Madrid
Clinica Universidad De Navarra
Department of Nephrology, Pio XII Etorbidea 36, 31008, Pamplona
Hospital Universitario Virgen De La Macarena
Nefrología. Planta 7ª D, Avenida Del Doctor Fedriani 3, 41009, Sevilla
Fundacio Puigvert
Department of Nephrology, Calle De Cartagena 340-350, 08025, Barcelona
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 |
|---|---|---|---|---|---|
| Austria | 2025-06-11 | 2025-06-26 | |||
| Belgium | 2026-03-30 | 2026-04-22 | |||
| Czechia | 2026-01-08 | ||||
| France | 2026-03-24 | 2026-05-19 | |||
| Greece | 2026-03-03 | 2026-04-02 | |||
| Latvia | 2025-11-10 | ||||
| Lithuania | 2025-12-17 | 2026-01-21 | |||
| Netherlands | 2025-12-11 | 2026-02-12 | |||
| Portugal | 2026-01-07 | 2026-01-23 | |||
| Spain | 2025-12-02 | 2026-02-19 | |||
| Sweden | 2025-12-16 | 2026-02-03 |
Application history
20 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-12-23 | Austria | Acceptable 2025-06-02
|
2025-06-02 |
| 2 | SUBSEQUENT ADDITION OF MSC | APP-2 | 2025-06-05 | 2025-08-27 | ||
| 3 | SUBSEQUENT ADDITION OF MSC | APP-3 | 2025-06-05 | Acceptable 2025-06-02
|
2025-08-26 | |
| 4 | SUBSEQUENT ADDITION OF MSC | APP-4 | 2025-06-06 | Acceptable 2025-06-02
|
2025-08-27 | |
| 5 | SUBSEQUENT ADDITION OF MSC | APP-5 | 2025-06-13 | Acceptable 2025-06-02
|
2025-09-01 | |
| 6 | SUBSEQUENT ADDITION OF MSC | APP-6 | 2025-06-13 | Acceptable 2025-06-02
|
2025-09-08 | |
| 7 | SUBSEQUENT ADDITION OF MSC | APP-7 | 2025-06-16 | Acceptable 2025-06-02
|
2025-09-04 | |
| 8 | SUBSEQUENT ADDITION OF MSC | APP-8 | 2025-06-18 | Acceptable 2025-06-02
|
2025-08-25 | |
| 9 | SUBSEQUENT ADDITION OF MSC | APP-9 | 2025-06-20 | Acceptable 2025-06-02
|
2025-09-12 | |
| 10 | SUBSEQUENT ADDITION OF MSC | APP-10 | 2025-06-20 | Acceptable 2025-06-02
|
2025-08-19 | |
| 11 | SUBSEQUENT ADDITION OF MSC | APP-11 | 2025-07-02 | Acceptable 2025-06-02
|
2025-09-08 | |
| 12 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-09-12 | Acceptable 2025-06-02
|
2025-09-12 | |
| 13 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-09-12 | Acceptable 2025-06-02
|
2025-09-12 | |
| 14 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-10-30 | Austria | Acceptable with conditions 2026-02-09
|
2026-02-09 |
| 15 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2026-02-17 | Austria | Acceptable with conditions 2026-02-09
|
2026-02-17 |
| 16 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2026-02-17 | Acceptable with conditions 2026-02-09
|
2026-02-17 | |
| 17 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2026-03-11 | Acceptable with conditions 2026-02-09
|
2026-03-11 | |
| 18 | NON SUBSTANTIAL MODIFICATION | NSM-6 | 2026-04-14 | Acceptable with conditions 2026-02-09
|
2026-04-14 | |
| 19 | NON SUBSTANTIAL MODIFICATION | NSM-7 | 2026-05-21 | Acceptable with conditions 2026-02-09
|
2026-05-21 | |
| 20 | NON SUBSTANTIAL MODIFICATION | NSM-8 | 2026-06-01 | Acceptable with conditions 2026-02-09
|
2026-06-01 |