Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Authorised, recruitment pending
Participants planned
42
Countries
1
Sites
1
Treatment of several inflammatory diseases, including inflammation-related fibrosis and autoinflammatory diseases
Key facts
- Sponsor
- Allinky Biopharma S.L.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Not possible to specify
- Decision date (initial)
- 2026-06-29
- 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
Treatment of several inflammatory diseases, including inflammation-related fibrosis and autoinflammatory diseases
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Allinky Biopharma S.L.
- Sponsor organisation
- Allinky Biopharma S.L.
- Address
- Calle De Faraday 7
- City
- Madrid
- Postcode
- 28049
- Country
- Spain
Scientific contact point
- Organisation
- Allinky Biopharma S.L.
- Contact name
- Clinical Department
Public contact point
- Organisation
- Allinky Biopharma S.L.
- Contact name
- Clinical Department
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Authorised, recruitment pending | 42 | 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 | 2026-04-09 | Spain | Acceptable 2026-06-24
|
2026-06-29 |