Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
41
Countries
1
Sites
1
Actinic keratosis
Key facts
- Sponsor
- Ankh Life Sciences Limited
- Participant type
- Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Trial duration
- 6 Aug 2024 → 31 Mar 2025
- Decision date (initial)
- 2024-07-12
- 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
Actinic keratosis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10000614 | Actinic keratosis | 100000004858 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Ankh Life Sciences Limited
- Sponsor organisation
- Ankh Life Sciences Limited
- Address
- 88 Harcourt Street
- City
- Dublin 2
- Postcode
- D02 DK18
- Country
- Ireland
Scientific contact point
- Organisation
- Ankh Life Sciences Limited
- Contact name
- Cameron West
Public contact point
- Organisation
- Ankh Life Sciences Limited
- Contact name
- Cameron West
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Sweden | Ended | 41 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
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 |
|---|---|---|---|---|---|
| Sweden | 2024-08-06 | 2025-03-31 | 2024-08-06 | 2025-03-13 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-04-29 | Sweden | Acceptable 2024-07-11
|
2024-07-12 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-11-28 | Sweden | Acceptable 2025-01-24
|
2025-01-30 |