Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
14
Countries
1
Sites
1
Hereditary angioedema (HAE)
Key facts
- Sponsor
- Pharvaris Netherlands B.V.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Skin and Connective Tissue Diseases [C17], Diseases [C] - Immune System Diseases [C20], Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
- Trial duration
- 13 Jun 2024 → 26 Jul 2024
- Decision date (initial)
- 2024-05-13
- 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
Hereditary angioedema (HAE)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 23.1 | PT | 10019860 | Hereditary angioedema | 100000004850 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Pharvaris Netherlands B.V.
- Sponsor organisation
- Pharvaris Netherlands B.V.
- Address
- J.h. Oortweg 21
- City
- Leiden
- Postcode
- 2333 CH
- Country
- Netherlands
Scientific contact point
- Organisation
- Pharvaris Netherlands B.V.
- Contact name
- Rafael Crabbé
Public contact point
- Organisation
- Pharvaris Netherlands B.V.
- Contact name
- Rafael Crabbé
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Hungary | Ended | 14 | 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 |
|---|---|---|---|---|---|
| Hungary | 2024-06-13 | 2024-07-26 | 2024-06-18 | 2024-06-25 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-03-11 | Hungary | Acceptable 2024-04-17
|
2024-05-13 |