Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Authorised, recruitment pending
Participants planned
7
Countries
1
Sites
1
Phenylketonuria
Key facts
- Sponsor
- Mipsalus ApS
- Participant type
- Healthy volunteers, Patients
- Age range
- 18-64 years
- Gender
- Male
- Therapeutic area
- Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Decision date (initial)
- 2026-06-17
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Phenylketonuria
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10034872 | Phenylketonuria | 100000004850 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Mipsalus ApS
- Sponsor organisation
- Mipsalus ApS
- Address
- Agern Alle 3
- City
- Hoersholm
- Postcode
- 2970
- Country
- Denmark
Scientific contact point
- Organisation
- Mipsalus ApS
- Contact name
- Clinical Operations
Public contact point
- Organisation
- Mipsalus ApS
- Contact name
- Clinical Operations
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Authorised, recruitment pending | 7 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Rigshospitalet
Centre Inherited Metabolic Diseases, Dept. Pediatrics and Clinical Genetics, Blegdamsvej 9, 2100, Copenhagen Oe
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-05-05 | Denmark | Acceptable 2026-06-16
|
2026-06-17 |