Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - Other
Status
Authorised, recruiting
Participants planned
130
Countries
3
Sites
16
Acute Ischemic Stroke
To assess the safety and tolerability of single intravenous (IV) doses of TGD001 in participants with an acute ischemic stroke (AIS) diagnosis, supported by neuroimaging, who either 1) receive endovascular thrombectomy (EVT), or 2) do not receive EVT or standard of care (SOC) intravenous thrombolysis (IVT).
Key facts
- Sponsor
- TargED Biopharmaceuticals B.V.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 17 Dec 2025 → ongoing
- Decision date (initial)
- 2025-11-03
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Safety
To assess the safety and tolerability of single intravenous (IV) doses of TGD001 in participants with an acute ischemic stroke (AIS) diagnosis, supported by neuroimaging, who either 1) receive endovascular thrombectomy (EVT), or 2) do not receive EVT or standard of care (SOC) intravenous thrombolysis (IVT).
Conditions and MedDRA coding
Acute Ischemic Stroke
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 22.1 | LLT | 10055221 | Ischemic stroke | 10029205 |
| 20.0 | SOC | 10029205 | Nervous system disorders | 8 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Age ≥18 and <80 years
- Functionally independent (mRS 0-2) prior to stroke onset
- Diagnosis of AIS supported by neuroimaging: a visible occlusion and/or an ischemic lesion (ASPECTS 6 - 10) with target mismatch
- Baseline NIHSS ≥5 and that remains ≥5 immediately before enrollment
- Participants who A) meet the local EVT eligibility requirements and undergo EVT or B) do not receive EVT or SOC IVT.
Exclusion criteria 3
- Intracranial hemorrhage on pre-intervention imaging
- Demarcated infarct or early ischemic changes resulting in an Alberta stroke program early CT score (ASPECTS) ≤5 on pre-intervention imaging
- Use of an anticoagulant, including but not limited to direct oral anticoagulants (DOAC) or warfarin, within the last 48 hours or recent oral anticoagulant therapy with an international normalized ratio (INR) ≥1.7.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- Symptomatic intracranial hemorrhage (sICH)
- Treatment emergent adverse events (TEAEs)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Urokinase, Catalytic Domain, Fused with a Single-Chain Antibody Against Von Willebrand Factor
PRD11531871 · Product
- Active substance
- Urokinase, Catalytic Domain, Fused with a Single-Chain Antibody Against Von Willebrand Factor
- Substance synonyms
- TGD001
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Authorisation status
- Not Authorised
- MA holder
- TARGED BIOPHARMACEUTICALS B.V.
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EMA/OD/0000167609
Placebo 1
SUB20079 · Substance
- Active substance
- Sodium Chloride Solution 0.9%
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
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 Contact TargED
Public contact point
- Organisation
- TargED Biopharmaceuticals B.V.
- Contact name
- Clinical Trial Contact TargED
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| SCIRENT Clinical Research and Science GmbH ORG-100050968
|
Berlin, Germany | On site monitoring, Code 10, Code 12, Code 2, Code 5, Code 8 |
Locations
3 EU/EEA countries · 16 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Authorised, recruiting | 20 | 8 |
| Poland | Authorised, recruiting | 25 | 3 |
| Spain | Authorised, recruiting | 35 | 5 |
| Rest of world
Serbia
|
— | 50 | — |
Investigational sites
Klinikum Ernst von Bergmann gGmbH
Neurologie, Charlottenstrasse 72, Noerdliche Innenstadt, Potsdam
Klinikum Altenburger Land GmbH
Neurologie, Am Waldessaum 10, 04600, Altenburg
Universitaetsklinikum Bonn AöR
Neurologie, Venusberg-Campus 1, Venusberg, Bonn
Asklepios Kliniken Hamburg GmbH
Neurologie, Alphonsstrasse 14, Marienthal, Hamburg
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
Neurologie, Fetscherstrasse 74, Johannstadt-Nord, Dresden
University Medical Center Hamburg-Eppendorf
Klinik und Poliklinikfür Neurologie, Martinistrasse 52, Eppendorf, Hamburg
Universitaetsklinikum Heidelberg AöR
Neurologie, Im Neuenheimer Feld 400, Neuenheim, Heidelberg
Universitätsklinikum Tübingen
Neurologie, Hoppe-Seyler-Strasse 3, 72076, Tübingen
Szpital Uniwersytecki W Krakowie
Oddzial Kliniczny Neurologil, ul. Jakubowskiego 2, 30-688, Krakow
Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy
Neurology, Ul. Kornela Ujejskiego 75, 85-168, Bydgoszcz
Gornoslaskie Centrum Medyczne Im Prof. Leszka Gieca Sląskiego Uniwersytetu Medycznego W Katowicach
Neurology, Ul. Ziolowa 45/47, 40-635, Katowice
University Hospital Virgen Del Rocio S.L.
Neurology, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital Universitario Virgen De La Macarena
Neurology, Avenida Del Doctor Fedriani 3, 41009, Sevilla
Hospital Alvaro Cunqueiro
Neurology, Estrada Clara Campoamor No 341, 36312, Vigo
University Clinical Hospital Virgen De La Arrixaca
Neurology, Carretera Madrid-Cartagena S/N, El Palmar, Murcia
Hospital Germans Trias I Pujol
Neurology, Carretera Canyet 1a Planta, 08916, Badalona
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 | 2025-12-17 | ||||
| Poland | 2025-12-17 | ||||
| Spain | 2025-12-17 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 16 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_redacted_2025-522455-26-00 | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_redacted | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment_arrangements_redacted | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment_arrangements_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF phase 1b_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF phase 1b_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF phase 1b_redacted | 2 |
| Subject information and informed consent form (for publication) | L2_SIS and ICF_phase 2a_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L2_SIS and ICF_phase 2a_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_SIS and ICF_phase 2a_redacted | 2 |
| Subject information and informed consent form (for publication) | L3_Information Notice_Payment Reimbursment Clinpharm _redacted | 2.0 |
| Subject information and informed consent form (for publication) | L3_SIS and ICF_Pregnant Participant_redacted | 1 |
| Subject information and informed consent form (for publication) | L3_SIS and ICF_Pregnant Partner_redacted | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis EN_redacted_2025-522455-26-00 | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis ES_redacted_2025-522455-26-00 | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis PL_redacted_2025-522455-26-00 | 2.0 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-07-09 | Germany | Acceptable 2025-10-27
|
2025-10-31 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-11-26 | Germany | Acceptable | 2025-12-17 |
| 3 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-11-26 | Acceptable | 2026-01-20 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-11-26 | Acceptable | 2025-12-23 | |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-02-27 | Germany | Acceptable | 2026-02-27 |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2026-04-08 | Germany | Acceptable | 2026-05-13 |