Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
14
Countries
1
Sites
1
Hereditary angioedema
Key facts
- Sponsor
- Pharvaris Netherlands B.V.
- 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
- 19 Sep 2024 → 12 Dec 2024
- Decision date (initial)
- 2024-09-09
- 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
Hereditary angioedema
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | 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
- Clinical Trials
Public contact point
- Organisation
- Pharvaris Netherlands B.V.
- Contact name
- Clinical Trials
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | 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 |
|---|---|---|---|---|---|
| Germany | 2024-09-19 | 2024-12-12 | 2024-09-19 | 2024-11-25 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-09 | Germany | Acceptable 2024-09-06
|
2024-09-09 |