Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
28
Countries
1
Sites
1
Healthy volunteers
Key facts
- Sponsor
- Municipal Institute Of Medical Investigation, Hospital Del Mar
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male
- Therapeutic area
- Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]
- Trial duration
- 27 Feb 2023 → 16 Oct 2024
- Decision date (initial)
- 2023-02-13
- 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
Municipal Institute Of Medical Investigation
- Sponsor organisation
- Municipal Institute Of Medical Investigation
- Address
- Calle Del Doctor Aiguader 80
- City
- Barcelona
- Postcode
- 08003
- Country
- Spain
Scientific contact point
- Organisation
- Hospital Del Mar
- Contact name
- Ana Maria Aldea Perona
Public contact point
- Organisation
- Hospital Del Mar
- Contact name
- Ana Maria Aldea Perona
Hospital Del Mar
- Sponsor organisation
- Hospital Del Mar
- Address
- Passeig Maritim De La Barceloneta 25-29
- City
- Barcelona
- Postcode
- 08003
- Country
- Spain
Scientific contact point
- Organisation
- Hospital Del Mar
- Contact name
- Ana Maria Aldea Perona
Public contact point
- Organisation
- Hospital Del Mar
- Contact name
- Ana Maria Aldea Perona
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ended | 28 | 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 | 2023-02-27 | 2024-10-16 | 2023-02-28 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2022-11-17 | Spain | Acceptable 2023-02-09
|
2023-02-13 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2023-11-21 | Spain | Acceptable 2024-02-20
|
2024-02-26 |