2025-522455-26-00RecruitingPhase 1/2
Evaluation of Novel Thrombolytic TGD001 in Patients With Acute Ischemic Stroke
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
Source: EU CTIS (euclinicaltrials.eu) · Last updated 13 May 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 9 Jul 2025
- Start date
- 17 Dec 2025
- Lead sponsor
- TargED Biopharmaceuticals B.V.
- Diseases
- Stroke
- EU CT number
- 2025-522455-26-00
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 80
- 16 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults under 80 who are having an acute ischemic stroke confirmed by brain imaging. They either have a clot removal procedure (EVT) or receive neither EVT nor standard clot-dissolving treatment.
- Age
- 18 to under 80 years
- Sex
- Women and men can join.
- Disease stage
- Acute ischemic stroke confirmed by brain imaging, with a visible blocked vessel and/or a lesion with ASPECTS 6-10 and target mismatch. NIHSS stroke score of 5 or more, also just before enrollment.
- Earlier treatment
- Must have been independent before the stroke (mRS 0-2). Must not have used an anticoagulant in the last 48 hours.
Main reasons for not taking part
- Bleeding inside the skull on imaging before treatment
- Clearly damaged brain area or early stroke changes with ASPECTS 5 or less
- Anticoagulant (such as DOAC or warfarin) in the last 48 hours
- Recent oral anticoagulant with INR 1.7 or higher
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Lab values
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (16)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Klinikum Altenburger Land GmbH | Altenburg | Germany | Recruiting |
| Universitaetsklinikum Bonn AöR | Bonn | Germany | Recruiting |
| Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR | Dresden | Germany | Recruiting |
| Asklepios Kliniken Hamburg GmbH | Hamburg | Germany | Recruiting |
| University Medical Center Hamburg-Eppendorf | Hamburg | Germany | Recruiting |
| Universitaetsklinikum Heidelberg AöR | Heidelberg | Germany | Recruiting |
| Klinikum Ernst von Bergmann gGmbH | Potsdam | Germany | Recruiting |
| Universitätsklinikum Tübingen | Tübingen | Germany | Recruiting |
| Hospital Germans Trias i Pujol | Badalona | Spain | Recruiting |
| University Clinical Hospital Virgen De La Arrixaca | Murcia | Spain | Recruiting |
| University Hospital Virgen Del Rocio S.L. | Sevilla | Spain | Recruiting |
| Hospital Universitario Virgen De La Macarena | Sevilla | Spain | Recruiting |
| Hospital Alvaro Cunqueiro | Vigo | Spain | Recruiting |
| Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy | Bydgoszcz | Poland | Recruiting |
| Gornoslaskie Centrum Medyczne Im Prof. Leszka Gieca Sląskiego Uniwersytetu Medycznego W Katowicach | Katowice | Poland | Recruiting |
| Szpital Uniwersytecki w Krakowie | Krakow | Poland | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.