Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
36
Countries
1
Sites
4
PLN R14del Dilated Cardiomyopathy
Key facts
- Sponsor
- AstraZeneca AB
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- 20 Nov 2025 → ongoing
- Decision date (initial)
- 2025-11-03
- 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
PLN R14del Dilated Cardiomyopathy
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 26.0 | PT | 10056419 | Dilated cardiomyopathy | 10007541 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
AstraZeneca AB
- Sponsor organisation
- AstraZeneca AB
- Address
- -
- City
- Sodertalje
- Postcode
- 151 85
- Country
- Sweden
Scientific contact point
- Organisation
- AstraZeneca AB
- Contact name
- Clinical Study Information Centre
Public contact point
- Organisation
- AstraZeneca AB
- Contact name
- Clinical Study Information Centre
Locations
1 EU/EEA country · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruiting | 36 | 4 |
| Rest of world | — | 0 | — |
Investigational sites
Universitair Medisch Centrum Utrecht
5003:Cardiology, Heidelberglaan 100, 3584 CX, Utrecht
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
5001:Cardiology, Dr. Molewaterplein 40, 3015 GD, Rotterdam
Amsterdam UMC Stichting
5004: unspecified, De Boelelaan 1117, 1081 HV, Amsterdam
Universitair Medisch Centrum Groningen
5002:Cardiology, Hanzeplein 1, 9713 GZ, 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 | 2025-11-20 | 2025-12-01 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-07-17 | Netherlands | Acceptable with conditions 2025-11-03
|
2025-11-03 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-01-08 | Netherlands | Acceptable 2026-02-27
|
2026-03-23 |