Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Authorised, recruitment pending
Participants planned
8
Countries
1
Sites
1
Healthy volunteers
Key facts
- Sponsor
- Oryzon Genomics S.A.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male
- Therapeutic area
- Not possible to specify
- Decision date (initial)
- 2026-04-30
- 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
Healthy volunteers
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
- Chief Scientific Officer
Public contact point
- Organisation
- Oryzon Genomics S.A.
- Contact name
- Chief Scientific Officer
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Authorised, recruitment pending | 8 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Pharmaceutical Research Associates Group B.V.
Program Management, Van Swietenlaan 6, 9728 NZ, Groningen
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-03-24 | Netherlands | Acceptable 2026-04-30
|
2026-04-30 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-05-19 | Netherlands | Acceptable | 2026-05-28 |