Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
20
Countries
1
Sites
1
Activated Phosphoinositide 3-Kinase Delta Syndrome
Key facts
- Sponsor
- Pharming Technologies B.V.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 29 Jan 2024 → 2 Apr 2024
- Decision date (initial)
- 2024-01-08
- 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
Activated Phosphoinositide 3-Kinase Delta Syndrome
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10078281 | Activated PI3 kinase delta syndrome | 100000004850 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Pharming Technologies B.V.
- Sponsor organisation
- Pharming Technologies B.V.
- Address
- Darwinweg 24
- City
- Leiden
- Postcode
- 2333 CR
- Country
- Netherlands
Scientific contact point
- Organisation
- Pharming Technologies B.V.
- Contact name
- Clinical Department
Public contact point
- Organisation
- Pharming Technologies B.V.
- Contact name
- Clinical Department
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ended | 20 | 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 | 2024-01-29 | 2024-04-02 | 2024-01-29 | 2024-02-20 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-10-11 | Germany | Acceptable 2024-01-05
|
2024-01-08 |