Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
78
Countries
1
Sites
1
Frontotemporal dementia (FTD)
Key facts
- Sponsor
- Insusense ApS, Insusense ApS
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]
- Trial duration
- 11 Oct 2023 → 26 Jul 2024
- Decision date (initial)
- 2023-10-11
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Frontotemporal dementia (FTD)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10068968 | Frontotemporal dementia | 100000004852 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Insusense ApS
- Sponsor organisation
- Insusense ApS
- Address
- Scherfigsvej 7
- City
- Copenhagen Oe
- Postcode
- 2100
- Country
- Denmark
Scientific contact point
- Organisation
- Insusense ApS
- Contact name
- Centre For Human Drug Research
Public contact point
- Organisation
- Insusense ApS
- Contact name
- Centre For Human Drug Research
Insusense ApS
- Sponsor organisation
- Insusense ApS
- Address
- 4th Floor, Hauser Plads 10 Hauser Plads 10
- City
- Copenhagen
- Postcode
- 1127
- Country
- Denmark
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ended | 78 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Centre for Human Drug Research
NA, 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 | 2023-10-11 | 2024-07-26 | 2023-10-19 | 2024-07-26 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-08-28 | Netherlands | Acceptable 2023-10-11
|
2023-10-11 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2023-11-29 | Netherlands | Acceptable 2023-10-11
|
2023-11-29 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-03-20 | Netherlands | Acceptable 2024-04-15
|
2024-04-15 |