Suspended

POST-ITPerfluorocarbon (ABL-101) Oxygenation for Stroke: Trial With GOLD (Glasgow Oxygen Level Dependent Technology) Imaging Theranostic (POST-IT)

What is being tested

ABL-101

+ 0.9% NaCl

DrugOther

Who is being recruted

Over 18 Years

+17 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Placebo-ControlledPhase 2

Interventional

Study Start: September 2018

See protocol details

Summary

Principal SponsorNHS Greater Glasgow and Clyde

Study ContactMaureen TraversMore contacts

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2018

Actual date on which the first participant was enrolled.

Only a small proportion of patients are currently suitable for treatment with "clot busting" drugs after a stroke. Being able to visualise potentially rescuable brain tissue on scanning may allow more people to be treated. Currently available methods require extra time to acquire and are not therefore widely used. By carrying significant extra oxygen to the brain, the ABL-101 molecule may not only allow the visualisation of salvageable tissue, but also prevent progression of stroke damage in and have an additional direct benefit on tissue survival. Studies in animal models of stroke show smaller areas of stroke damage after ABL-101. There is therefore a rationale for testing this molecule in stroke patients, both as a diagnostic method, and also as a potential therapeutic agent.

Official TitlePerfluorocarbon (ABL-101) Oxygenation for Stroke: Trial With GOLD (Glasgow Oxygen Level Dependent Technology) Imaging Theranostic (POST-IT)

NCT03463551

Principal SponsorNHS Greater Glasgow and Clyde

Study ContactMaureen TraversMore contacts

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

18 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

5 inclusion criteria required to participate

Aged ≥18 years.

Males or females not of child-bearing potential defined as being post-menopausal based on cessation of regular menses for a minimum of 12 consecutive months with no alternative cause, permanently sterilised (e.g. hysterectomy, bilateral tubal occlusion, bilateral salpingectomy), or having medically confirmed ovarian failure.

Ischaemic stroke <72h after onset.

Previous functional independence (estimated mRS <3).

Show More Criteria

12 exclusion criteria prevent from participating

Women of child bearing potential.

Contraindications to MRI scanning (eg cardiac pacemaker, ferromagnetic implants, known hypersensitivity to gadolinium containing contrast media).

Known allergy to ABL-101 or any of its constituents, (including egg phospholipids).

Clinical need for, or contraindication to, supplemental oxygen.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental

Patients will receive either ABL-101 or placebo (equivalent volume of 0.9% Sodium Chloride) within ascending dose groups of 6 patients each (4 to ABL-101, 2 to placebo).The starting cohort will be Cohort 1: 0.5mL/kg. In the event that the start dose of Cohort 1 is considered intolerable in the opinion of the iDMC based on incidence of patients experiencing dose-limiting toxicities (DLTs), the iDMC will have the option of recommending a lower dose cohort (Cohort -1) of 0.25ml/kg (to a maximum of 25ml) be undertaken. Cohort 1: 0.5 mL/kg to a maximum of 50ml; Cohort 2: 1.5mL/kg to a maximum of 150ml; Cohort 3: 3.0mL/kg to a maximum of 300ml. All patients will receive Oxygen 60% by face mask (8l/min) for approximately 24h after ABL-101 or placebo administration.

Group II

Placebo

Cohort 1: Volume matched to the calculation used for ABL-101 using patient weight; Cohort 2: Volume matched to the calculation used for ABL-101 using patient weight; Cohort 3: Volume matched to the calculation used for ABL-101 using patient weight. All patients will receive Oxygen 60% by face mask (8l/min) for approximately 24h after ABL-101 or placebo administration.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

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SuspendedNo study centers