Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Authorised, recruitment pending
Participants planned
72
Countries
1
Sites
1
Autosomal Dominant Polycystic Kidney Disease
Key facts
- Sponsor
- Mironid Limited
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
- Decision date (initial)
- 2026-04-01
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Autosomal Dominant Polycystic Kidney Disease
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10036046 | Polycystic kidney autosomal dominant | 10010331 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Mironid Limited
- Sponsor organisation
- Mironid Limited
- Address
- John Arbuthnott Building, 161 Cathedral Street 161 Cathedral Street
- City
- Glasgow
- Postcode
- G4 0RE
- Country
- United Kingdom
Scientific contact point
- Organisation
- Mironid Limited
- Contact name
- Neil Wilkie
Public contact point
- Organisation
- Mironid Limited
- Contact name
- Neil Wilkie
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Authorised, recruitment pending | 72 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Pharmaceutical Research Associates Group B.V.
Program Management, Van Swietenlaan 6, 9728 NZ, Groningen
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-02-20 | Netherlands | Acceptable 2026-04-01
|
2026-04-01 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-05-18 | Netherlands | Acceptable | 2026-05-21 |