Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
33
Countries
1
Sites
1
Dermal tolerability test: Testing for non-specific, local irritating reactions on intact skin using mean cumulative irritation score (CIS).
Key facts
- Sponsor
- Grindeks AS
- Participant type
- Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Phenomena and Processes [G] - Cell Physiological Phenomena [G04], Phenomena and Processes [G] - Physiological processes [G07]
- Trial duration
- 20 Jun 2024 → 22 Jul 2024
- Decision date (initial)
- 2024-06-07
- 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
Dermal tolerability test: Testing for non-specific, local irritating reactions on intact skin using mean cumulative irritation score (CIS).
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Grindeks AS
- Sponsor organisation
- Grindeks AS
- Address
- Krustpils Iela 53
- City
- Riga
- Postcode
- 1057
- Country
- Latvia
Scientific contact point
- Organisation
- Grindeks AS
- Contact name
- Head of Drug Research and Intellectual Property Group
Public contact point
- Organisation
- Grindeks AS
- Contact name
- Head of Drug Research and Intellectual Property Group
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ended | 33 | 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 |
|---|---|---|---|---|---|
| Germany | 2024-06-20 | 2024-07-22 | 2024-06-26 | 2024-07-01 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-03-27 | Germany | Acceptable 2024-06-06
|
2024-06-07 |