Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
38
Countries
1
Sites
1
Soil-transmitted helminth infection
Key facts
- Sponsor
- Bayer AG
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Parasitic Diseases [C03]
- Trial duration
- 4 Feb 2025 → 30 Apr 2025
- Decision date (initial)
- 2024-11-28
- 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
Soil-transmitted helminth infection
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10030314 | Onchocerciasis | 100000004862 |
| 20.0 | PT | 10061201 | Helminthic infection | 100000004862 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Bayer AG
- Sponsor organisation
- Bayer AG
- Address
- -
- City
- Leverkusen
- Postcode
- 51368
- Country
- Germany
Scientific contact point
- Organisation
- Bayer AG
- Contact name
- Therapeutic Area Head
Public contact point
- Organisation
- Bayer AG
- Contact name
- Therapeutic Area Head
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ended | 38 | 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 | 2025-02-04 | 2025-04-30 | 2025-02-13 | 2025-03-21 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-10 | Germany | Acceptable 2024-11-13
|
2024-11-28 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-12-19 | Germany | Acceptable 2025-01-10
|
2025-01-14 |