Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Not authorised
Participants planned
80
Countries
1
Sites
1
Ovarian cancer
Key facts
- Sponsor
- Kancera AB
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Decision date (initial)
- 2023-08-09
- 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
Ovarian cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10033128 | Ovarian cancer | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Kancera AB
- Sponsor organisation
- Kancera AB
- Address
- Banvaktsvagen 22
- City
- Solna
- Postcode
- 171 48
- Country
- Sweden
Scientific contact point
- Organisation
- Kancera AB
- Contact name
- Thomas Olin
Public contact point
- Organisation
- Kancera AB
- Contact name
- Thomas Olin
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Finland | Not authorised | 80 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-04-21 | Finland | Not acceptable 2023-08-07
|
2023-08-09 |