Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruiting
Participants planned
68
Countries
1
Sites
2
Neonatal Hypoxic-Ischemic Encephalopathy (HIE)
Key facts
- Sponsor
- Chiesi Farmaceutici S.p.A.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
- Trial duration
- 11 Sep 2025 → ongoing
- Decision date (initial)
- 2025-08-05
- 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
Neonatal Hypoxic-Ischemic Encephalopathy (HIE)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 25.0 | PT | 10086943 | Hypoxic ischaemic encephalopathy neonatal | 100000004868 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Chiesi Farmaceutici S.p.A.
- Sponsor organisation
- Chiesi Farmaceutici S.p.A.
- Address
- Via Palermo 26/a
- City
- Parma
- Postcode
- 43122
- Country
- Italy
Scientific contact point
- Organisation
- Chiesi Farmaceutici S.p.A.
- Contact name
- GLOBAL CLINICAL DEVEOPMENT
Public contact point
- Organisation
- Chiesi Farmaceutici S.p.A.
- Contact name
- GLOBAL CLINICAL DEVEOPMENT
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Bulgaria | Ongoing, recruiting | 68 | 2 |
| 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 |
|---|---|---|---|---|---|
| Bulgaria | 2025-09-11 | 2025-09-15 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-05-15 | Bulgaria | Acceptable 2025-08-05
|
2025-08-05 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-10-17 | Bulgaria | Acceptable 2025-08-05
|
2025-10-17 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-11-21 | Bulgaria | Acceptable 2026-01-06
|
2026-01-07 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-01-16 | Bulgaria | Acceptable | 2026-02-27 |