Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
37
Countries
1
Sites
1
Cholestatic liver disease
Key facts
- Sponsor
- ProQR Therapeutics VIII B.V.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Trial duration
- 3 Nov 2025 → ongoing
- Decision date (initial)
- 2025-10-14
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Cholestatic liver disease
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | HLGT | 10019654 | Hepatic and hepatobiliary disorders | 10019805 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
ProQR Therapeutics VIII B.V.
- Sponsor organisation
- ProQR Therapeutics VIII B.V.
- Address
- Zernikedreef 9
- City
- Leiden
- Postcode
- 2333 CK
- Country
- Netherlands
Scientific contact point
- Organisation
- ProQR Therapeutics VIII B.V.
- Contact name
- Clinical Operations
Public contact point
- Organisation
- ProQR Therapeutics VIII B.V.
- Contact name
- Clinical Operations
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruiting | 37 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Pharmaceutical Research Associates Group B.V.
Program Menagement, 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 | 2025-11-03 | 2025-12-05 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-06-26 | Netherlands | Acceptable with conditions 2025-10-13
|
2025-10-14 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-10-15 | Netherlands | Acceptable with conditions 2025-10-13
|
2025-10-15 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-10-30 | Netherlands | Acceptable with conditions 2025-10-13
|
2025-10-30 |
| 4 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-03-03 | Netherlands | Acceptable with conditions | 2026-03-16 |