Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
40
Countries
1
Sites
2
Parkinson’s Disease
Key facts
- Sponsor
- Herantis Pharma Oyj
- Participant type
- Patients, Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 18 Sep 2024 → 14 Aug 2025
- Decision date (initial)
- 2024-09-03
- 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
Parkinson’s Disease
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10061536 | Parkinson's disease | 100000004852 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Herantis Pharma Oyj
- Sponsor organisation
- Herantis Pharma Oyj
- Address
- Bertel Jungin Aukio 1
- City
- Espoo
- Postcode
- 02600
- Country
- Finland
Scientific contact point
- Organisation
- Herantis Pharma Oyj
- Contact name
- Head of Clinical Operations
Public contact point
- Organisation
- Herantis Pharma Oyj
- Contact name
- Head of Clinical Operations
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Finland | Ended | 40 | 2 |
| 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 |
|---|---|---|---|---|---|
| Finland | 2024-09-18 | 2025-08-14 | 2024-09-23 | 2025-07-04 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-05-17 | Finland | Acceptable 2024-09-02
|
2024-09-03 |