Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
50
Countries
1
Sites
3
Acute respiratory distress syndrome (ARDS) caused by SARS-Cov-2, influenza A, influenza B and respiratory syncytial virus (RSV)
Key facts
- Sponsor
- Peaches Biotech S.L.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Virus Diseases [C02]
- Trial duration
- 2 Oct 2024 → ongoing
- Decision date (initial)
- 2024-01-22
- 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 respiratory distress syndrome (ARDS) caused by SARS-Cov-2, influenza A, influenza B and respiratory syncytial virus (RSV)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10001052 | Acute respiratory distress syndrome | 100000004855 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Peaches Biotech S.L.
- Sponsor organisation
- Peaches Biotech S.L.
- Address
- Calle De Isabel Colbrand 6
- City
- Madrid
- Postcode
- 28050
- Country
- Spain
Scientific contact point
- Organisation
- Peaches Biotech S.L.
- Contact name
- Francesca Sarno
Public contact point
- Organisation
- Peaches Biotech S.L.
- Contact name
- Francesca Sarno
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ongoing, recruiting | 50 | 3 |
| Rest of world | — | 0 | — |
Investigational sites
Hospital Universitario Reina Sofia
Servicio Enfermedades Infecciosas, Avenida Menendez Pidal S/n, 14004, Cordoba
Hospital Universitario Principe De Asturias
Medicina Interna, Carretera Meco S/n, 28805, Alcala De Henares
Hospital Universitario De Fuenlabrada
Medicina Interna, Camino Del Molino 2, 28942, Fuenlabrada
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 | 2024-10-02 | 2024-11-13 |
Application history
7 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-10-12 | Spain | Acceptable with conditions 2024-01-22
|
2024-01-22 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-07-26 | Spain | Acceptable 2024-09-11
|
2024-09-11 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-10-14 | Spain | Acceptable 2024-09-11
|
2024-10-14 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-05-07 | Spain | Acceptable 2025-06-23
|
2025-06-23 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-08-06 | Spain | Acceptable 2025-06-23
|
2025-08-06 |
| 6 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-11-24 | Spain | Acceptable | 2026-01-15 |
| 7 | SUBSTANTIAL MODIFICATION | SM-4 | 2026-02-20 | Spain | Acceptable with conditions 2026-05-11
|
2026-05-13 |