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Safety and Tolerability of Adjunctive TBO-309 in Reperfusion for Stroke
Sponsor: The Florey Institute of Neuroscience and Mental Health
Summary
STARS is a prospective, multicentre, open-label, dose escalation, Phase IIa study to assess the safety and tolerability of TBO-309, an adjuvant antiplatelet therapy, in patients with AIS. Acute ischaemic stroke (AIS) is caused by a severe blockage of an artery leading to immediate reduced blood flow to part of the brain. Standard therapies target the blocked artery by either dissolving the blockage or removing the blockage. However, even after successful treatment, re-blockage of arteries can occur. The use of an antiplatelet therapy, TBO-309, in addition to standard therapies offers the possibility of improved restoration of blood flow and reduced rates of artery re-blockage.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
80
Start Date
2023-09-27
Completion Date
2026-05-01
Last Updated
2025-12-01
Healthy Volunteers
No
Conditions
Interventions
TBO-309
TBO-309 is a potent, selective and ATP competitive PI3Kβ inhibitor which blocks platelet activation adhesion/aggregation and promotes platelet disaggregation, thereby specifically inhibiting thrombosis without interfering with normal haemostasis.
Locations (7)
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
Liverpool Hospital
Liverpool, New South Wales, Australia
John Hunter Hospital
New Lambton Heights, New South Wales, Australia
Prince of Wales Hospital
Randwick, New South Wales, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Eastern Health- Box Hill Hospital
Box Hill, Victoria, Australia
Royal Melbourne Hospital
Parkville, Victoria, Australia