Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruiting
Participants planned
40
Countries
1
Sites
1
healthy volunteers undergoing induced sedation
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
- Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Trial duration
- 9 Sep 2025 → ongoing
- Decision date (initial)
- 2025-03-31
- 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 undergoing induced sedation
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 26.0 | LLT | 10088820 | Clinical trial healthy volunteer | 100000004848 |
| 20.0 | PT | 10039897 | Sedation | 100000004852 |
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
- Ana Aldea
Public contact point
- Organisation
- Consorci Mar Parc De Salut De Barcelona
- Contact name
- Marta López
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ongoing, recruiting | 40 | 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 | 2025-09-09 | 2025-09-16 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-12-20 | Spain | Acceptable with conditions 2025-03-28
|
2025-03-31 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-05-13 | Spain | Acceptable 2025-07-18
|
2025-07-22 |