Clinical trial • Phase I/II • Neurology
UROKINASE, CATALYTIC DOMAIN, FUSED WITH A SINGLE-CHAIN ANTIBODY AGAINST VON WILLEBRAND FACTOR for Acute ischemic stroke
Phase I/II trial of UROKINASE, CATALYTIC DOMAIN, FUSED WITH A SINGLE-CHAIN ANTIBODY AGAINST VON WILLEBRAND FACTOR for Acute ischemic stroke.
Overview
- Trial Therapeutic Area
- Neurology
- Trial Disease
- Acute ischemic stroke
- Trial Stage
- Phase I/II
- Drug Modality
- Peptide/protein/enzyme|Small molecule
- Orphan Drug
- Yes
Key dates
- Initial CTIS Submission Date
- 09-07-2025
- First CTIS Authorization Date
- 31-10-2025
Trial design
Randomised, open-label, sodium chloride solution 0.9% (placebo), intravenous; dose/schedule not specified in the record-controlled, adaptive Phase I/II trial across 16 sites in Poland, Spain, Germany.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- SODIUM CHLORIDE SOLUTION 0.9% (placebo), intravenous; dose/schedule not specified in the record
- Adaptive
- True, includes a dose-finding (Phase 1b) escalation followed by randomized expansion; specific escalation rules/interim analyses/stopping rules not provided
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 80
Eligibility
Recruits 80 Vulnerable population selected; no specific consent/assent handling details available in the provided record..
- Vulnerable Population
- Vulnerable population selected; no specific consent/assent handling details available in the provided record.
Inclusion criteria
- {"criterion_text":"- Age ≥18 and <80 years"}
- {"criterion_text":"- Functionally independent (mRS 0-2) prior to stroke onset"}
- {"criterion_text":"- Diagnosis of AIS supported by neuroimaging: a visible occlusion and/or an ischemic lesion (ASPECTS 6 - 10) with target mismatch"}
- {"criterion_text":"- Baseline NIHSS ≥5 and that remains ≥5 immediately before enrollment"}
- {"criterion_text":"- Participants who A) meet the local EVT eligibility requirements and undergo EVT or B) do not receive EVT or SOC IVT."}
Exclusion criteria
- {"criterion_text":"- Intracranial hemorrhage on pre-intervention imaging"}
- {"criterion_text":"- Demarcated infarct or early ischemic changes resulting in an Alberta stroke program early CT score (ASPECTS) ≤5 on pre-intervention imaging"}
- {"criterion_text":"- 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 endpoints
- {"endpoint_text":"- Symptomatic intracranial hemorrhage (sICH)","definition_or_measurement_approach":""}
- {"endpoint_text":"- Treatment emergent adverse events (TEAEs)","definition_or_measurement_approach":""}
Recruitment
- Planned Sample Size
- 80
- Recruitment Window Months
- 24
- Consent Approach
- Informed consent obtained using subject information and informed consent forms; ICF/SIS documents listed for phase 1b and phase 2a and available in multiple languages (English, Spanish, Polish). No detailed description of assent or age-specific consent handling available in the record.
Geography
- Total Number Of Sites
- 16
- Total Number Of Participants
- 80
Poland
- Earliest CTIS Part Ii Submission Date
- 01-10-2025
- Latest Decision Or Authorization Date
- 20-01-2026
- Processing Time Days
- 111
- Number Of Sites
- 3
- Number Of Participants
- 25
Sites
- Site Name
- Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy
- Department Name
- Neurology
- Principal Investigator Name
- Violetta Palacz-Duda
- Principal Investigator Email
- violettapduda@gmail.com
- Contact Person Name
- Violetta Palacz-Duda
- Contact Person Email
- violettapduda@gmail.com
- Site Name
- Gornoslaskie Centrum Medyczne Im Prof. Leszka Gieca Sląskiego Uniwersytetu Medycznego W Katowicach
- Department Name
- Neurology
- Principal Investigator Name
- Anetta Lasek-Bal
- Principal Investigator Email
- alasek@gcm.pl
- Contact Person Name
- Anetta Lasek-Bal
- Contact Person Email
- alasek@gcm.pl
- Site Name
- Szpital Uniwersytecki W Krakowie
- Department Name
- Oddzial Kliniczny Neurologil
- Principal Investigator Name
- Agnieska Slowik
- Principal Investigator Email
- neurologiabk@su.krakow.pl
- Contact Person Name
- Agnieska Slowik
- Contact Person Email
- neurologiabk@su.krakow.pl
Spain
- Earliest CTIS Part Ii Submission Date
- 28-07-2025
- Latest Decision Or Authorization Date
- 23-12-2025
- Processing Time Days
- 148
- Number Of Sites
- 5
- Number Of Participants
- 35
Sites
- Site Name
- University Clinical Hospital Virgen De La Arrixaca
- Department Name
- Neurology
- Principal Investigator Name
- Ana Morales Ortiz
- Principal Investigator Email
- amoralesortiz@gmail.com
- Contact Person Name
- Ana Morales Ortiz
- Contact Person Email
- amoralesortiz@gmail.com
- Site Name
- University Hospital Virgen Del Rocio S.L.
- Department Name
- Neurology
- Principal Investigator Name
- Francisco Moniche Álvarez
- Principal Investigator Email
- pmoniche@gmail.com
- Contact Person Name
- Francisco Moniche Álvarez
- Contact Person Email
- pmoniche@gmail.com
- Site Name
- Hospital Universitario Virgen De La Macarena
- Department Name
- Neurology
- Principal Investigator Name
- Miguel Ángel Gamero García
- Principal Investigator Email
- gamero.ma@gmail.com
- Contact Person Name
- Miguel Ángel Gamero García
- Contact Person Email
- gamero.ma@gmail.com
- Site Name
- Hospital Germans Trias I Pujol
- Department Name
- Neurology
- Principal Investigator Name
- María Hernández Pérez
- Principal Investigator Email
- mhernandez@igtp.cat
- Contact Person Name
- María Hernández Pérez
- Contact Person Email
- mhernandez@igtp.cat
- Site Name
- Hospital Alvaro Cunqueiro
- Department Name
- Neurology
- Principal Investigator Name
- Pablo Vicente Alba
- Principal Investigator Email
- pablo.vicente.alba@sergas.es
- Contact Person Name
- Pablo Vicente Alba
- Contact Person Email
- pablo.vicente.alba@sergas.es
Germany
- Earliest CTIS Part Ii Submission Date
- 11-09-2025
- Latest Decision Or Authorization Date
- 13-05-2026
- Processing Time Days
- 244
- Number Of Sites
- 8
- Number Of Participants
- 20
Sites
- Site Name
- Universitaetsklinikum Bonn AöR
- Department Name
- Neurologie
- Principal Investigator Name
- Johannes Weller
- Principal Investigator Email
- Johannes.Weller@ukbonn.de
- Contact Person Name
- Johannes Weller
- Contact Person Email
- Johannes.Weller@ukbonn.de
- Site Name
- Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
- Department Name
- Neurologie
- Principal Investigator Name
- Patrick Schramm
- Principal Investigator Email
- patrick.schramm@ukdd.de
- Contact Person Name
- Patrick Schramm
- Contact Person Email
- patrick.schramm@ukdd.de
- Site Name
- University Medical Center Hamburg-Eppendorf
- Department Name
- Klinik und Poliklinikfür Neurologie
- Principal Investigator Name
- Thomalla Götz
- Principal Investigator Email
- thomalla@uke.de
- Contact Person Name
- Thomalla Götz
- Contact Person Email
- thomalla@uke.de
- Site Name
- Klinikum Altenburger Land GmbH
- Department Name
- Neurologie
- Principal Investigator Name
- Jörg Berroushot
- Principal Investigator Email
- joerg.berrouschot@klinikum-altenburgerland.de
- Contact Person Name
- Jörg Berroushot
- Contact Person Email
- joerg.berrouschot@klinikum-altenburgerland.de
- Site Name
- Klinikum Ernst von Bergmann gGmbH
- Department Name
- Neurologie
- Principal Investigator Name
- Andrea Rocco
- Principal Investigator Email
- andrea.rocco@klinikumevb.de
- Contact Person Name
- Andrea Rocco
- Contact Person Email
- andrea.rocco@klinikumevb.de
- Site Name
- Universitaetsklinikum Heidelberg AöR
- Department Name
- Neurologie
- Principal Investigator Name
- Jan Purrucker
- Principal Investigator Email
- Jan.Purrucker@med.uni-heidelberg.de
- Contact Person Name
- Jan Purrucker
- Contact Person Email
- Jan.Purrucker@med.uni-heidelberg.de
- Site Name
- Asklepios Kliniken Hamburg GmbH
- Department Name
- Neurologie
- Principal Investigator Name
- Lars Marquardt
- Principal Investigator Email
- l.marquardt@asklepios.com
- Contact Person Name
- Lars Marquardt
- Contact Person Email
- l.marquardt@asklepios.com
- Site Name
- Universitätsklinikum Tübingen
- Department Name
- Neurologie
- Principal Investigator Name
- Annerose Mengel
- Principal Investigator Email
- annerose.mengel@uni-tuebingen.de
- Contact Person Name
- Annerose Mengel
- Contact Person Email
- annerose.mengel@uni-tuebingen.de
Sponsor
Primary sponsor
- Full Name
- TargED Biopharmaceuticals B.V.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Netherlands
Contract research organisations
- Name
- SCIRENT Clinical Research and Science GmbH
- Responsibilities
- sponsorDuties codes: 1,10,12,2,5,8; regulatory and sponsor support (contact scirent_regulatoryaffairs@scirent.com)
Third parties
- {"country":"Germany","full_name":"SCIRENT Clinical Research and Science GmbH","duties_or_roles":"sponsorDuties codes: 1,10,12,2,5,8; contact: scirent_regulatoryaffairs@scirent.com","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- TGD001
- Active Substance
- UROKINASE, CATALYTIC DOMAIN, FUSED WITH A SINGLE-CHAIN ANTIBODY AGAINST VON WILLEBRAND FACTOR
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- INTRAVENOUS
- Route
- INTRAVENOUS
- Orphan Designation
- Yes
- Investigational Product Name
- SODIUM CHLORIDE SOLUTION 0.9%
- Active Substance
- SODIUM CHLORIDE SOLUTION 0.9%
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS
- Route
- INTRAVENOUS
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