Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Authorised, recruiting
Participants planned
69
Countries
2
Sites
3
Olmsted syndrome
Key facts
- Sponsor
- Orvida Pharma Ltd.
- Participant type
- Patients, Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Trial duration
- 27 Jun 2025 → ongoing
- Decision date (initial)
- 2025-06-25
- 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
Olmsted syndrome
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 27.0 | PT | 10068842 | Olmsted syndrome | 100000004850 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Orvida Pharma Ltd.
- Sponsor organisation
- Orvida Pharma Ltd.
- Address
- Science Park, 3 Pinkhas Sapir 3 Pinkhas Sapir
- City
- Nes Tsiyona
- Postcode
- 7403626
- Country
- Israel
Scientific contact point
- Organisation
- Kamari Pharma Ltd.
- Contact name
- Liora Braiman
Public contact point
- Organisation
- Kamari Pharma Ltd.
- Contact name
- Liora Braiman
Locations
2 EU/EEA countries · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 64 | 2 |
| Germany | Authorised, recruitment pending | 2 | 1 |
| Rest of world
United Kingdom
|
— | 3 | — |
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 |
|---|---|---|---|---|---|
| France | 2025-06-27 | 2025-06-30 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-03-27 | France | Acceptable with conditions 2025-06-25
|
2025-06-25 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-09-26 | France | Acceptable with conditions 2025-06-25
|
2025-09-26 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-01-08 | France | Acceptable 2026-03-20
|
2026-03-20 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-03-23 | France | Acceptable | 2026-04-02 |
| 5 | SUBSEQUENT ADDITION OF MSC | APP-5 | 2026-04-03 | Acceptable 2026-03-20
|
2026-06-18 | |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2026-06-22 | France | Acceptable 2026-03-20
|
2026-06-22 |