Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
48
Countries
1
Sites
1
Proteinopathies
Key facts
- Sponsor
- Asceneuron S.A.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 22 Feb 2024 → 3 Jul 2024
- Decision date (initial)
- 2024-02-20
- 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
Proteinopathies
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | HLGT | 10037008 | Protein and amino acid metabolism disorders NEC | 10027433 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Asceneuron S.A.
- Sponsor organisation
- Asceneuron S.A.
- Address
- Building B, Batiment Epfl Innovation Park Batiment Epfl Innovation Park
- City
- Lausanne
- Postcode
- 1015
- Country
- Switzerland
Scientific contact point
- Organisation
- Asceneuron S.A.
- Contact name
- Head of Early Clinical Development
Public contact point
- Organisation
- Asceneuron S.A.
- Contact name
- Head of Early Clinical Development
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ended | 48 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Pharmaceutical Research Associates Group B.V.
Early Clinical Services, Amerikaweg 18, 9407 TK, Assen
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 | 2024-02-22 | 2024-07-03 | 2024-02-22 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-02-09 | Netherlands | Acceptable 2024-02-20
|
2024-02-20 |