Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
36
Countries
1
Sites
1
Nervous System disease
Key facts
- Sponsor
- Chugai Pharmaceutical Co. Ltd.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 6 Dec 2024 → 10 Mar 2026
- Decision date (initial)
- 2024-12-03
- 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
Nervous System disease
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Chugai Pharmaceutical Co. Ltd.
- Sponsor organisation
- Chugai Pharmaceutical Co. Ltd.
- Address
- 5-1 Ukima 5-Chome
- City
- Kita-Ku
- Postcode
- 115-0051
- Country
- Japan
Scientific contact point
- Organisation
- Chugai Pharmaceutical Co. Ltd.
- Contact name
- Clinical trials information
Public contact point
- Organisation
- Chugai Pharmaceutical Co. Ltd.
- Contact name
- Clinical trials information
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ended | 36 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Centre for Human Drug Research
n.a., Zernikedreef 8, 2333 CL, Leiden
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 | 2024-12-06 | 2026-03-10 | 2024-12-16 | 2025-11-20 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-07 | Netherlands | Acceptable 2024-12-03
|
2024-12-03 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-02-17 | Netherlands | Acceptable 2024-12-03
|
2025-02-17 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-03-13 | Netherlands | Acceptable 2025-03-25
|
2025-03-26 |