Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Authorised, recruitment pending
Participants planned
129
Countries
1
Sites
1
Erosive Gastroesophageal Reflux Disease (eGERD)
Key facts
- Sponsor
- Cinclus Pharma Holding AB (publ)
- Participant type
- Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Digestive System Diseases [C06]
- Decision date (initial)
- 2024-08-16
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-516261-36-00
- EudraCT number
- 2022-001375-14
- ClinicalTrials.gov
- NCT05469854
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Erosive Gastroesophageal Reflux Disease (eGERD)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.1 | LLT | 10017924 | Gastroesophageal reflux | 10017947 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Cinclus Pharma Holding AB (publ)
- Sponsor organisation
- Cinclus Pharma Holding AB (publ)
- Address
- Kungsbron 1 Plan 3 Trappa G
- City
- Stockholm
- Postcode
- 111 22
- Country
- Sweden
Scientific contact point
- Organisation
- Cinclus Pharma Holding AB (publ)
- Contact name
- Kajsa Larsson
Public contact point
- Organisation
- Cinclus Pharma Holding AB (publ)
- Contact name
- Kajsa Larsson
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Sweden | Authorised, recruitment pending | 129 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-07 | Sweden | Acceptable with conditions 2024-08-16
|
2024-08-16 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-10-18 | Sweden | Acceptable 2025-01-16
|
2025-01-16 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-04-09 | Sweden | Acceptable 2025-05-19
|
2025-05-26 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2026-01-09 | Sweden | Acceptable 2026-03-13
|
2026-03-16 |