RecruitingPhase IIInterventional

Evaluation of novel thrombolytic TGD001 in patients with acute ischemic stroke

An ischaemic stroke happens when a blood clot blocks blood flow to part of the brain. While current treatments can dissolve or remove clots, they do not work for everyone. This trial is investigating a new medicine called TGD001, which targets blood clots in a new way to help clear blockages. The study aims to test the safety of TGD001 and see whether it helps people recover after a stroke. It is open to adults who arrive at specialist hospital stroke units with a confirmed stroke. Participants will receive either TGD001 or standard care (sometimes with a dummy drug called a placebo) as a single dose into a vein. Doctors will track recovery, perform brain scans, and check for side effects over about 90 days. The findings may help improve emergency stroke treatments in the future.

At a glance

Status

Recruiting

Phase

Phase II

Sponsor

TargED Biopharmaceuticals B.V.

Enrolment target

130

Start

11 Mar 2026

Estimated completion

06 Dec 2027

Acute ischemic stroke

What is this study about?

An ischaemic stroke is a medical emergency caused by a blood clot cutting off oxygen and nutrients to brain cells. When brain cells are starved of blood, they quickly become damaged, which can lead to life-changing physical and cognitive difficulties. Hospital teams currently use clot-busting drugs or physical clot-removal procedures to restore blood supply. However, these options are not suitable for every patient and do not always clear the blockage completely, so new therapies are urgently needed.

This study evaluates a new drug called TGD001. Most existing clot-busting drugs break down a mesh called fibrin. TGD001 works differently by targeting a protein called von Willebrand factor, which acts like glue holding clots together. Scientists hope this alternative approach will safely break down stubborn clots and restore healthy blood flow to delicate brain tissue.

The main purpose of this Phase II study is to find out if TGD001 is safe to use and well-tolerated by patients in the acute phase of a stroke. Researchers also want to discover the most effective dose and see whether it improves patients' day-to-day recovery compared to standard care alone.

Taking part in research like this helps medical teams develop smarter, faster emergency treatments. If TGD001 proves successful, it could offer a valuable new tool to reduce brain damage and long-term disability for future stroke patients across the UK and worldwide.

Key takeaways

Testing a new clot-dissolving medicine (TGD001) for acute ischaemic stroke.
Aims to safely break down blood clots and restore blood flow to the brain.
Given as a single drip in a specialist hospital stroke unit.
Follows participants for 90 days to check recovery and side effects.
Participation is voluntary and does not stop standard stroke care.

Who may be eligible?

You or your loved one may be considered for this study if you are an adult aged 18 or older who has had a sudden ischaemic stroke confirmed by emergency brain scans. Participants must have been largely independent in their daily activities before the stroke happened, and the stroke symptoms must be noticeable enough to meet the trial's score criteria.

This trial is not suitable for everyone. People cannot join if their brain scans show bleeding in the brain or if they have an active bleed anywhere else in the body. Those taking certain strong blood-thinning medications (such as warfarin or direct oral anticoagulants) within the last 48 hours are generally excluded, as these drugs raise the chance of bleeding.

In addition, people who cannot have MRI or CT scans, or women who are pregnant or breastfeeding, cannot take part. Because stroke treatment must happen quickly, hospital doctors will assess eligibility immediately on arrival.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Aged 18 years or older.
Recently diagnosed with an acute ischaemic stroke confirmed by a brain scan.
Able to live independently before this stroke occurred.
No history of active internal bleeding or bleeding in the brain.
Not currently pregnant, breastfeeding, or taking certain strong blood thinners.

Answer every question to see your result.

What does participation involve?

Taking part takes place during emergency hospital admission and continues for around 90 days. The medicine is given as a single dose through a drip into a vein. In the first phase of the trial, small groups receive different doses of TGD001 so doctors can find the best amount. In the second phase, patients are randomly chosen to receive either TGD001 or a placebo (an inactive saline solution), alongside their regular stroke treatment. Neither you nor your doctor can choose which one you receive in this phase. During your stay and at follow-up visits over the next three months, the study team will carry out brain scans (CT and MRI), take blood samples, and check your physical recovery and ability to carry out everyday activities.

Potential risks and benefits

There is no guarantee that taking part will improve your recovery, as TGD001 is still being tested. However, you will receive close medical observation from stroke specialists, and the information collected may help future stroke patients. Like all clot-dissolving medications, the main risk of TGD001 is bleeding, which could happen inside the brain or in other parts of the body. There is also a small chance of allergic reactions, as well as minor discomfort from drips and scans. Taking part is completely voluntary; you or your family representative can say no or withdraw at any time without your standard NHS medical care being affected.

Locations (26)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Royal Stoke University Hospital
Unverified
Stoke-on-trent, England
Kings College Hospital
Unverified
London, England
Royal Victoria Infirmary
Unverified
Newcastle upon Tyne, England
University College London Hospitals NHS Foundation Trust
Unverified
London, England
University Hospital Hamburg-Eppendorf
Unverified
Hamburg, Germany
Klinikum Altenburg Land
Unverified
Altenburg, Germany
Universitätsklinikum Heidelberg
Unverified
Heidelberg, Germany
Klinikum Ernst von Bergmann
Unverified
Potsdam, Germany
Uniklinikum Dresden
Unverified
Dresden, Germany
Universitätsklinikum Bonn
Unverified
Bonn, Germany
Universitätsklinikum Tübingen
Unverified
Tübingen, Germany
Universitätsmedizin Charité
Unverified
Berlin, Germany

Common questions

Will I still receive standard stroke treatment?

Yes. Your medical team will continue to provide the appropriate standard stroke care, including emergency procedures if you need them.

What is a placebo?

A placebo is an inactive substance that looks identical to the study medicine. In the second stage of the trial, it is used to see if the improvements are genuinely caused by TGD001.

How long will I be involved in the study?

You will receive the study medicine once in the hospital, and doctors will monitor your health and recovery for about 90 days afterwards.

What happens if I cannot give consent because of my stroke?

If you are too unwell to make a decision, a family member, legal representative, or independent doctor can provide permission on your behalf in line with UK clinical trial laws.

Does it cost anything to participate?

No. The study medication and all trial-related tests are provided free of charge, and taking part will not affect your routine NHS care.

How to find out more

Josefin-Beate Holz

regulatory@Targedbio.com +31 (0)30 2028079 ext 00 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.