Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
21
Countries
1
Sites
1
No medical condition.
Key facts
- Sponsor
- Chemo Research S.L.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Female
- Therapeutic area
- Not possible to specify
- Trial duration
- 28 May 2025 → 13 Sep 2025
- Decision date (initial)
- 2025-05-08
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
No medical condition.
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Chemo Research S.L.
- Sponsor organisation
- Chemo Research S.L.
- Address
- 3rd Floor, Calle De Manuel Pombo Angulo 28 Calle De Manuel Pombo Angulo 28
- City
- Madrid
- Postcode
- 28050
- Country
- Spain
Scientific contact point
- Organisation
- Chemo Research S.L.
- Contact name
- Enrico Colli
Public contact point
- Organisation
- Chemo Research S.L.
- Contact name
- Enrico Colli
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Portugal | Ended | 21 | 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 |
|---|---|---|---|---|---|
| Portugal | 2025-05-28 | 2025-09-13 | 2025-05-28 | 2025-06-16 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-03-21 | Portugal | Acceptable 2025-05-02
|
2025-05-08 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-05-13 | Portugal | Acceptable 2025-05-19
|
2025-05-19 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-09-17 | Portugal | Acceptable 2025-05-19
|
2025-09-17 |