Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
51
Countries
1
Sites
1
Not applicable, healthy volunteers
Key facts
- Sponsor
- InflaRx GmbH
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Not possible to specify
- Trial duration
- 14 Jun 2024 → 16 Apr 2025
- Decision date (initial)
- 2024-06-13
- 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
Not applicable, healthy volunteers
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
InflaRx GmbH
- Sponsor organisation
- InflaRx GmbH
- Address
- Winzerlaer Strasse 2, Ammerbach Ammerbach
- City
- Jena
- Postcode
- 07745
- Country
- Germany
Scientific contact point
- Organisation
- InflaRx GmbH
- Contact name
- Derval O´Carroll
Public contact point
- Organisation
- InflaRx GmbH
- Contact name
- Derval O´Carroll
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ended | 51 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Pharmaceutical Research Associates Group B.V.
Program Management, Van Swietenlaan 6, 9728 NZ, Groningen
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 |
|---|---|---|---|---|---|
| Netherlands | 2024-06-14 | 2025-04-16 | 2024-06-17 | 2025-03-13 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-04-25 | Netherlands | Acceptable 2024-06-13
|
2024-06-13 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-12-13 | Netherlands | Acceptable 2025-01-14
|
2025-01-14 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-03-28 | Netherlands | Acceptable 2025-01-14
|
2025-03-28 |