This study evaluates the safety and tolerability of 3 dose levels of ABL-101 and supplemental oxygen in acute stroke patients.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
18
To evaluate the safety and tolerability of 3 dose levels of ABL-101 and supplemental oxygen in acute stroke patients.
Incidence of Serious Adverse Events and AEs of special interest up to visit 6 (day 7±2).
Time frame: 7 days±2
Mortality
Time frame: 30 days
Incidence of serious adverse events throughout the entire study period.
Time frame: 30 days±5
Incidence of adverse events of special interest
Time frame: 30 days±5
Incidence of adverse reactions, adverse events, serious adverse events and serious adverse reactions, up to visit 7 (30±5 days) post administration of Investigational medicinal product.
Time frame: 30 days±5
Modified Rankin Scale (mRS) distribution at day 30.
The mRS is a hierarchical ordinal scale used to assess disability in stroke trials, with seven discrete levels that range from No Symptoms (mRS=0) to death (mRS=6). The Rankin Focused Assessment tool will be used to derive day 30 mRS.
Time frame: At day 30
Follow-up infarct volume on MRI brain at visit 4.
Time frame: 48hrs (40-72hrs)
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