Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
24
Countries
1
Sites
2
No medical conditions.
Key facts
- Sponsor
- Chemo Research S.L.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Female
- Therapeutic area
- Not possible to specify
- Trial duration
- 16 Dec 2025 → 4 May 2026
- Decision date (initial)
- 2025-12-02
- 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
No medical conditions.
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
- Chief Scientific Officer
Public contact point
- Organisation
- Chemo Research S.L.
- Contact name
- Chief Scientific Officer
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ended | 24 | 2 |
| 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 | 2025-12-16 | 2025-12-17 | 2026-04-20 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-08-11 | Spain | Acceptable with conditions 2025-11-28
|
2025-12-02 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-12-09 | Spain | Acceptable with conditions 2025-11-28
|
2025-12-09 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-12-15 | Spain | Acceptable with conditions 2025-11-28
|
2025-12-15 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2026-01-28 | Spain | Acceptable with conditions 2025-11-28
|
2026-01-28 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2026-04-30 | Spain | Acceptable with conditions 2025-11-28
|
2026-04-30 |