Evaluation of Novel Thrombolytic TGD001 in Patients With Acute Ischemic Stroke
Key facts
- Where
- Altenburg, Bonn, Dresden, Hamburg, Heidelberg, Potsdam és Tübingen, NémetországSee the 8 sites
- Phase
- 1/2. fázis
Where in Németország
- Klinikum Altenburger Land GmbHAltenburg, NémetországTaking people
- Universitaetsklinikum Bonn AöRBonn, NémetországTaking people
- Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöRDresden, NémetországTaking people
- Asklepios Kliniken Hamburg GmbHHamburg, NémetországTaking people
- University Medical Center Hamburg-EppendorfHamburg, NémetországTaking people
- Universitaetsklinikum Heidelberg AöRHeidelberg, NémetországTaking people
- Klinikum Ernst von Bergmann gGmbHPotsdam, NémetországTaking people
- Universitätsklinikum TübingenTübingen, NémetországTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- TargED Biopharmaceuticals B.V.
- Trial code
- EU 2025-522455-26-00
- Record updated
- 2026. május 13.
- Original description
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).Read full original descriptionShow less
A Phase 1b/2a Open-Label Dose-Finding Followed by Randomized, Double-Blind, Placebo-Controlled Expansion Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of TGD001 in Patients with 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).
Inclusion: 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: 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.