Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
64
Countries
1
Sites
1
Pain
Key facts
- Sponsor
- Sea4us Biotecnologia E Recursos Marinhos S.A.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Trial duration
- 25 May 2026 → ongoing
- Decision date (initial)
- 2026-04-16
- 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
Pain
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Sea4us Biotecnologia E Recursos Marinhos S.A.
- Sponsor organisation
- Sea4us Biotecnologia E Recursos Marinhos S.A.
- Address
- Armazem 8, Porto Da Baleeira Sagres Porto Da Baleeira Sagres
- City
- Sagres
- Postcode
- 8650-368
- Country
- Portugal
Scientific contact point
- Organisation
- Sea4us Biotecnologia E Recursos Marinhos S.A.
- Contact name
- Eduardo Moura
Public contact point
- Organisation
- Sea4us Biotecnologia E Recursos Marinhos S.A.
- Contact name
- Eduardo Moura
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ongoing, recruiting | 64 | 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 |
|---|---|---|---|---|---|
| Spain | 2026-05-25 | 2026-05-26 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-04-14 | Spain | Acceptable 2026-04-15
|
2026-04-16 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-05-22 | Spain | Acceptable 2026-04-15
|
2026-05-22 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-05-22 | Spain | Acceptable 2026-04-15
|
2026-05-22 |