Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
44
Countries
1
Sites
1
Atopic Dermatitis
Key facts
- Sponsor
- Rubedo Life Sciences Italy S.R.L.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Trial duration
- 4 Apr 2025 → 11 Mar 2026
- Decision date (initial)
- 2025-04-02
- 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
Atopic Dermatitis
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Rubedo Life Sciences Italy S.R.L.
- Sponsor organisation
- Rubedo Life Sciences Italy S.R.L.
- Address
- Via Porlezza 12
- City
- Milan
- Postcode
- 20123
- Country
- Italy
Scientific contact point
- Organisation
- Rubedo Life Sciences Italy S.R.L.
- Contact name
- Chief Medical Officer
Public contact point
- Organisation
- Rubedo Life Sciences Italy S.R.L.
- Contact name
- Chief Medical Officer
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ended | 44 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Centre for Human Drug Research
Internal medicine, Zernikedreef 8, 2333 CL, Leiden
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 |
|---|---|---|---|---|---|
| Netherlands | 2025-04-04 | 2026-03-11 | 2025-04-22 | 2026-01-08 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-01-27 | Netherlands | Acceptable 2025-04-02
|
2025-04-02 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-06-25 | Netherlands | Acceptable 2025-04-02
|
2025-06-25 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-08-11 | Netherlands | Acceptable 2025-09-16
|
2025-09-16 |