Overview
Sponsor-declared trial summary
A Phase I randomized, double-blind, placebo-controlled study to assess the safety and pharmacokinetics of single-ascending doses of TGD001 in healthy volunteers
Key facts
- Sponsor
- TargED Biopharmaceuticals B.V.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- 14 Mar 2025 → 22 Jul 2025
- Decision date (initial)
- 2024-11-13
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
A Phase I randomized, double-blind, placebo-controlled study to assess the safety and pharmacokinetics of single-ascending doses of TGD001 in healthy volunteers
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
TargED Biopharmaceuticals B.V.
- Sponsor organisation
- TargED Biopharmaceuticals B.V.
- Address
- Princetonlaan 6
- City
- Utrecht
- Postcode
- 3584 CB
- Country
- Netherlands
Scientific contact point
- Organisation
- TargED Biopharmaceuticals B.V.
- Contact name
- Clinical trial information
Public contact point
- Organisation
- TargED Biopharmaceuticals B.V.
- Contact name
- Clinical trial information
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ended | 0 | 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 | 2024-11-18 | 2025-07-22 | 2024-11-18 | 2025-06-13 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 1 · Art. 38 CTR
Temporary halt TH-73811
- Halt date
- 2025-02-21
- Planned restart
- 2025-03-15
- Member states concerned
- Germany
- Publication date
- 2025-03-07
- Reason
- Study management related
- Explanation
- Please refer to 'Note file on Cohort 2', dated 07Mar25
- Follow-up measures
- please refer to 'Note to file on Cohort 2', dated 07Mar25
- Benefit-risk balance changed
- No
- Treatment stopped
- Yes
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-16 | Germany | Acceptable 2024-11-13
|
2024-11-13 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-07-22 | Acceptable 2024-11-13
|
||
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-07-22 | Germany | 2025-07-22 |