Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
36
Countries
1
Sites
1
Immuno-oncology assessments
Key facts
- Sponsor
- Centre for Human Drug Research
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Not possible to specify
- Trial duration
- 13 Dec 2023 → 9 Apr 2026
- Decision date (initial)
- 2023-12-08
- 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
Immuno-oncology assessments
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Centre for Human Drug Research
- Sponsor organisation
- Centre for Human Drug Research
- Address
- Zernikedreef 8
- City
- Leiden
- Postcode
- 2333 CL
- Country
- Netherlands
Scientific contact point
- Organisation
- Centre for Human Drug Research
- Contact name
- Principal investigator
Public contact point
- Organisation
- Centre for Human Drug Research
- Contact name
- Principal investigator
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
Immunology, 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 | 2023-12-13 | 2023-12-28 | 2024-04-16 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 1 · Art. 38 CTR
Temporary halt TH-23371
- Halt date
- 2024-04-16
- Member states concerned
- Netherlands
- Publication date
- 2024-04-29
- Reason
- Investigator/Site related
- Explanation
- Please refer to the document uploaded under Related document(s)
- Follow-up measures
- Please refer to the document uploaded under Related document(s)
- Benefit-risk balance changed
- No
- Treatment stopped
- Yes
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-11-06 | Netherlands | Acceptable 2023-12-08
|
2023-12-08 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-03-11 | Netherlands | Acceptable 2023-12-08
|
2024-03-11 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-05-16 | Netherlands | Acceptable 2025-06-02
|
2025-06-02 |