Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
15
Countries
1
Sites
1
Sepsis and Septic Shock
Key facts
- Sponsor
- Matisse Pharmaceuticals B.V.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Bacterial Infections and Mycoses [C01]
- Trial duration
- 12 Mar 2025 → 18 Jun 2025
- Decision date (initial)
- 2024-10-16
- 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
Sepsis and Septic Shock
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 23.1 | PT | 10040070 | Septic shock | 100000004862 |
| 20.0 | PT | 10040047 | Sepsis | 100000004862 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Matisse Pharmaceuticals B.V.
- Sponsor organisation
- Matisse Pharmaceuticals B.V.
- Address
- Burg. Lemmensstraat 352
- City
- Geleen
- Postcode
- 6163 JT
- Country
- Netherlands
Scientific contact point
- Organisation
- Matisse Pharmaceuticals B.V.
- Contact name
- Clinical trial information desk”
Public contact point
- Organisation
- Matisse Pharmaceuticals B.V.
- Contact name
- Clinical trial information desk”
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ended | 15 | 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 | 2024-10-17 | 2025-06-18 | 2024-10-17 | 2025-06-05 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 1 · Art. 38 CTR
Temporary halt TH-63524
- Halt date
- 2024-12-06
- Member states concerned
- Germany
- Publication date
- 2024-12-17
- Reason
- Safety related (clinical or pre-clinical results)
- Follow-up measures
- Please refer to the attachment.
- Benefit-risk balance changed
- Yes
- Treatment stopped
- Yes
Corrective measures 1 · Art. 77 CTR
Corrective measure CM-DE-0001
- Member state
- Germany
- Publication date
- 2025-02-07
- Type
- 3
- Reason
- 7
- Immediate action required
- No
- Justification
- Ad hoc assessment has been started, but no anwer of the sponsor has been received to the safety related issues. Reminder remains without any reply of the sponsor.
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-22 | Germany | Acceptable 2024-10-14
|
2024-10-16 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-01-30 | Germany | Acceptable 2025-02-24
|
2025-03-12 |