Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
52
Countries
1
Sites
1
Pulmonary fibrosis
Key facts
- Sponsor
- Gat Therapeutics S.L.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Respiratory Tract Diseases [C08]
- Trial duration
- 1 Oct 2024 → 12 Oct 2025
- Decision date (initial)
- 2023-11-27
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Pulmonary fibrosis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10022619 | Interstitial pulmonary fibrosis | 10038738 |
| 21.0 | PT | 10037383 | Pulmonary fibrosis | 100000004855 |
| 21.1 | PT | 10021240 | Idiopathic pulmonary fibrosis | 100000004855 |
| 20.0 | LLT | 10016660 | Fibrosis pulmonary | 10038738 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Gat Therapeutics S.L.
- Sponsor organisation
- Gat Therapeutics S.L.
- Address
- Calle Baldiri Reixac 4-10, Poligono Industrial Parc Cientific De Barcelona Poligono Industrial Parc Cientific De Barcelona
- City
- Barcelona
- Postcode
- 08028
- Country
- Spain
Scientific contact point
- Organisation
- Gat Therapeutics S.L.
- Contact name
- Administration
Public contact point
- Organisation
- Gat Therapeutics S.L.
- Contact name
- Administration
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ended | 52 | 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 |
|---|---|---|---|---|---|
| Spain | 2024-10-01 | 2025-10-12 | 2024-10-01 | 2025-09-08 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-08-25 | Spain | Acceptable with conditions 2023-11-20
|
2023-11-27 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-07-18 | Spain | Acceptable 2024-08-29
|
2024-08-29 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-10-07 | Spain | Acceptable 2025-01-03
|
2025-01-03 |