Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Authorised, recruitment pending
Participants planned
50
Countries
1
Sites
1
Acute eosinophilic esophagitis
Key facts
- Sponsor
- Dr. Falk Pharma GmbH
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Digestive System Diseases [C06], Diseases [C] - Immune System Diseases [C20]
- Decision date (initial)
- 2026-07-07
- 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
Acute eosinophilic esophagitis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.1 | LLT | 10064220 | Eosinophilic esophagitis | 10017947 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Dr. Falk Pharma GmbH
- Sponsor organisation
- Dr. Falk Pharma GmbH
- Address
- Leinenweberstrasse 5, Hochdorf Hochdorf
- City
- Freiburg Im Breisgau
- Postcode
- 79108
- Country
- Germany
Scientific contact point
- Organisation
- Dr. Falk Pharma GmbH
- Contact name
- CTIS – Scientific Request
Public contact point
- Organisation
- Dr. Falk Pharma GmbH
- Contact name
- Clinical Research and Development
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Sweden | Authorised, recruitment pending | 50 | 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 | 2026-05-22 | Sweden | Acceptable 2026-07-07
|
2026-07-07 |