Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Not authorised
Participants planned
20
Countries
1
Sites
1
Hepatocellular carcinoma, renal cell carcinoma and differentiated thyroid carcinoma.
Key facts
- Sponsor
- Disruptive Pharma AB
- Participant type
- Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Not possible to specify
- Decision date (initial)
- 2024-08-27
- 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
Hepatocellular carcinoma, renal cell carcinoma and differentiated thyroid carcinoma.
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10073071 | Hepatocellular carcinoma | 100000004864 |
| 21.1 | LLT | 10007476 | Carcinoma thyroid | 10029104 |
| 21.1 | PT | 10067946 | Renal cell carcinoma | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Disruptive Pharma AB
- Sponsor organisation
- Disruptive Pharma AB
- Address
- Uppsala Science Park
- City
- Uppsala
- Postcode
- 751 83
- Country
- Sweden
Scientific contact point
- Organisation
- Disruptive Pharma AB
- Contact name
- Malin Vågerö, Director R&D
Public contact point
- Organisation
- Disruptive Pharma AB
- Contact name
- Peter Åsberg, CEO
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Sweden | Not authorised | 20 | 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 | 2024-06-07 | Sweden | Not acceptable 2024-08-27
|
2024-08-27 |