Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
40
Countries
1
Sites
1
healthy volunteers
Key facts
- Sponsor
- Reckitt Benckiser Healthcare (UK) Limited
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Not possible to specify
- Trial duration
- 21 Jul 2025 → 14 Aug 2025
- Decision date (initial)
- 2025-06-11
- 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
healthy volunteers
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Reckitt Benckiser Healthcare (UK) Limited
- Sponsor organisation
- Reckitt Benckiser Healthcare (UK) Limited
- Address
- Dansom Lane
- City
- Hull
- Postcode
- HU8 7DS
- Country
- United Kingdom
Scientific contact point
- Organisation
- Reckitt Benckiser Healthcare (UK) Limited
- Contact name
- Sarah Reed
Public contact point
- Organisation
- Reckitt Benckiser Healthcare (UK) Limited
- Contact name
- Sarah Reed
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ended | 40 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
SGS proderm GmbH
Clinical Research Unit, Kiebitzweg 2, 22869, Schenefeld
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 | 2025-07-21 | 2025-08-14 | 2025-07-21 | 2025-08-04 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-04-11 | Germany | Acceptable 2025-06-10
|
2025-06-11 |