Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
32
Countries
1
Sites
1
Healthy volunteers
Key facts
- Sponsor
- Bial Portela & Ca S.A.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 29 Apr 2025 → 24 Jul 2025
- Decision date (initial)
- 2025-04-08
- 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
Healthy volunteers
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10061536 | Parkinson's disease | 100000004852 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Bial Portela & Ca S.A.
- Sponsor organisation
- Bial Portela & Ca S.A.
- Address
- A Avenida Da Siderurgia Nacional
- City
- Sao Mamede Do Coronado
- Postcode
- 4745-457
- Country
- Portugal
Scientific contact point
- Organisation
- Bial Portela & Ca S.A.
- Contact name
- scientific contact
Public contact point
- Organisation
- Bial Portela & Ca S.A.
- Contact name
- scientific contact
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 32 | 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 | 2025-04-29 | 2025-07-24 | 2025-04-29 | 2025-07-01 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-03-06 | Belgium | Acceptable 2025-04-08
|
2025-04-08 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-04-17 | Belgium | Acceptable 2025-05-07
|
2025-05-08 |