Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruitment ended
Participants planned
48
Countries
1
Sites
1
Septic cholestasis
Key facts
- Sponsor
- SmartDyeLivery GmbH
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Bacterial Infections and Mycoses [C01]
- Trial duration
- 2 Apr 2026 → ongoing
- Decision date (initial)
- 2024-11-15
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-518889-27-00
- EudraCT number
- 2022-003872-18
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Septic cholestasis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10008638 | Cholestasis intrahepatic | 10019805 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
SmartDyeLivery GmbH
- Sponsor organisation
- SmartDyeLivery GmbH
- Address
- Botzstrasse 5, West West
- City
- Jena
- Postcode
- 07743
- Country
- Germany
Scientific contact point
- Organisation
- SmartDyeLivery GmbH
- Contact name
- Clinical Trial Management
Public contact point
- Organisation
- SmartDyeLivery GmbH
- Contact name
- Clinical Trial Management
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ongoing, recruitment ended | 48 | 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 | 2025-01-31 | 2025-01-31 | 2025-12-12 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 2 · Art. 38 CTR
Temporary halt TH-112037
- Halt date
- 2025-12-12
- Member states concerned
- Germany
- Publication date
- 2025-12-18
- Reason
- Sponsor decision
- Explanation
- Please refer to the attached document.
- Follow-up measures
- Please refer to the attached document.
- Benefit-risk balance changed
- No
- Treatment stopped
- Yes
Temporary halt TH-88481
- Halt date
- 2025-06-25
- Member states concerned
- Germany
- Publication date
- 2025-06-30
- Reason
- Sponsor decision
- Explanation
- Please refer to the attached document.
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Application history
7 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-17 | Germany | Acceptable 2024-11-06
|
2024-11-15 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-12-11 | Germany | Acceptable 2025-01-30
|
2025-01-31 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-02-11 | Germany | Acceptable 2025-01-30
|
2025-02-11 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-07-24 | Germany | Acceptable 2025-08-13
|
2025-08-13 |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-08-27 | Germany | Acceptable 2025-09-17
|
2025-09-18 |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-10-23 | Germany | Acceptable 2025-11-10
|
2025-11-11 |
| 7 | SUBSTANTIAL MODIFICATION | SM-5 | 2026-04-02 | Germany | Acceptable 2026-04-17
|
2026-04-20 |