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Taking people in GermanyPhase 1/2

Testing TGD001 in adults with acute ischemic stroke

Tests a new clot-dissolving drug, TGD001, in adults with acute stroke.

Key facts

Who runs it
TargED Biopharmaceuticals B.V.
Where
Altenburg, Bonn, Dresden, Hamburg, Heidelberg, Potsdam, and Tübingen, GermanySee the 8 sitesAlso in 2 other countries, 8 sites
Registry title
Evaluation of Novel Thrombolytic TGD001 in Patients With Acute Ischemic Stroke
Status
Recruiting
Phase
Phase 1/2
People taking part
80 people, planned
Started
17 Dec 2025
Expected to end
1 Oct 2027
Type of study
Interventional
Record updated
13 May 2026

Who can take part

AI summary

From the trial's eligibility criteria. 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

The registry criteria, word for word

Show all 8 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Where in Germany

Also in 2 other countries, 8 sites

  • Klinikum Altenburger Land GmbHAltenburg, GermanyTaking people
  • Universitaetsklinikum Bonn AöRBonn, GermanyTaking people
  • Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöRDresden, GermanyTaking people
  • Asklepios Kliniken Hamburg GmbHHamburg, GermanyTaking people
  • University Medical Center Hamburg-EppendorfHamburg, GermanyTaking people
  • Universitaetsklinikum Heidelberg AöRHeidelberg, GermanyTaking people
  • Klinikum Ernst von Bergmann gGmbHPotsdam, GermanyTaking people
  • Universitätsklinikum TübingenTübingen, GermanyTaking people

About the trial

What the trial wants to find out

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).

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
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
Plain-language title
Testing TGD001 in adults with acute ischemic strokeGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 9 November 2026.
Record updated
13 May 2026