Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruiting
Participants planned
30
Countries
1
Sites
7
Sickle Cell Disease
Key facts
- Sponsor
- Oryzon Genomics S.A.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Hemic and Lymphatic Diseases [C15]
- Trial duration
- 16 Oct 2025 → ongoing
- Decision date (initial)
- 2025-08-20
- 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
Sickle Cell Disease
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Oryzon Genomics S.A.
- Sponsor organisation
- Oryzon Genomics S.A.
- Address
- Avinguda De Sant Ferran 74, Poligono Industrial Cornella De Llobregat Poligono Industrial Cornella De Llobregat
- City
- Cornella De Llobregat
- Postcode
- 08940
- Country
- Spain
Scientific contact point
- Organisation
- Oryzon Genomics S.A.
- Contact name
- Director Clinical Operations
Public contact point
- Organisation
- Oryzon Genomics S.A.
- Contact name
- Director Clinical Operations
Locations
1 EU/EEA country · 7 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ongoing, recruiting | 30 | 7 |
| Rest of world | — | 0 | — |
Investigational sites
Hospital Universitario La Paz
Hematology, Paseo De La Castellana 261, 28046, Madrid
Hospital Clínic Barcelona
Hematology, Villarroel 170, 08036, Barcelona
Hospital De La Santa Creu I Sant Pau
Hematology, Calle De San Antonio Maria Claret 167, 08025, Barcelona
Hospital General Universitario Gregorio Maranon
Hematology, Calle Del Doctor Esquerdo 46, 28009, Madrid
Hospital Universitari Vall D Hebron
Hematology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
University Hospital Virgen Del Rocio S.L.
Hematology, Avenida De Manuel Siurot S/n, 41013, Sevilla
Institut Catala D'oncologia
Hematology, Carretera Canyet S/n, 08916, Badalona
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 |
|---|---|---|---|---|---|
| Spain | 2025-10-16 | 2025-10-30 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-05-15 | Spain | Acceptable 2025-08-16
|
2025-08-20 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-11-24 | Spain | Acceptable | 2025-12-09 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-04-14 | Spain | Acceptable | 2026-04-14 |