Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruiting
Participants planned
18
Countries
1
Sites
1
Iron overload from thalassemia, transfusion-dependent myelodysplastic syndromea and haemolysis
Key facts
- Sponsor
- Pharmacosmos A/S
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Hemic and Lymphatic Diseases [C15]
- Trial duration
- 10 Apr 2026 → ongoing
- Decision date (initial)
- 2026-04-07
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2025-525025-12-00
- WHO UTN
- U1111-1310-4466
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Iron overload from thalassemia, transfusion-dependent myelodysplastic syndromea and haemolysis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.1 | LLT | 10054660 | Thalassemia beta | 10010331 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Pharmacosmos A/S
- Sponsor organisation
- Pharmacosmos A/S
- Address
- Roervangsvej 30
- City
- Holbaek
- Postcode
- 4300
- Country
- Denmark
Scientific contact point
- Organisation
- Pharmacosmos A/S
- Contact name
- Lars Lykke Thomsen
Public contact point
- Organisation
- Pharmacosmos A/S
- Contact name
- Amalie Bjerre Jørgensen
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruiting | 18 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Pharmaceutical Research Associates Group B.V.
Program Management, Van Swietenlaan 6, 9728 NZ, Groningen
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 | 2026-04-10 | 2026-04-22 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-02-24 | Netherlands | Acceptable 2026-04-07
|
2026-04-07 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-04-22 | Netherlands | Acceptable 2026-04-07
|
2026-04-22 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-05-07 | Netherlands | Acceptable 2026-04-07
|
2026-05-07 |