Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
8
Countries
1
Sites
1
healthy volunteers
Key facts
- Sponsor
- Consorci Mar Parc De Salut De Barcelona
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Not possible to specify
- Trial duration
- 14 May 2025 → 7 Oct 2025
- Decision date (initial)
- 2025-04-15
- 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
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 26.0 | LLT | 10088820 | Clinical trial healthy volunteer | 100000004848 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Consorci Mar Parc De Salut De Barcelona
- Sponsor organisation
- Consorci Mar Parc De Salut De Barcelona
- Address
- Passeig Maritim De La Barceloneta 25-29
- City
- Barcelona
- Postcode
- 08003
- Country
- Spain
Scientific contact point
- Organisation
- Consorci Mar Parc De Salut De Barcelona
- Contact name
- Head of clínica Trial Unit_Ana Aldea
Public contact point
- Organisation
- Consorci Mar Parc De Salut De Barcelona
- Contact name
- Head of clínical Trial Unit
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ended | 8 | 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 | 2025-05-14 | 2025-10-07 | 2025-06-12 | 2025-09-08 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-12-09 | Spain | Acceptable 2025-04-11
|
2025-04-15 |