Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruiting
Participants planned
27
Countries
1
Sites
1
Huntington's disease
Key facts
- Sponsor
- CHDI Foundation Inc.
- Participant type
- Patients, Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
- Trial duration
- 24 Feb 2026 → ongoing
- Decision date (initial)
- 2024-12-17
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-515786-34-02
- EudraCT number
- 2022-004221-41
- ClinicalTrials.gov
- NCT06634628
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Huntington's disease
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
CHDI Foundation Inc.
- Sponsor organisation
- CHDI Foundation Inc.
- Address
- 350 7th Avenue
- City
- New York
- Postcode
- 10001-5013
- Country
- United States
Scientific contact point
- Organisation
- CHDI Foundation Inc.
- Contact name
- Prof Wim Vandenberghe
Public contact point
- Organisation
- CHDI Foundation Inc.
- Contact name
- Prof Wim Vandenberghe
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruiting | 27 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
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 |
|---|---|---|---|---|---|
| Belgium | 2026-02-24 | 2026-02-26 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-12-11 | Belgium | Acceptable 2024-12-17
|
2024-12-17 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-06-10 | Belgium | Acceptable 2025-07-07
|
2025-07-31 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-01-07 | Belgium | Acceptable 2026-01-27
|
2026-01-29 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-04-02 | Belgium | Acceptable 2026-01-27
|
2026-04-02 |