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RECRUITING
NCT05363397
PHASE2

Safety and Tolerability of Adjunctive TBO-309 in Reperfusion for Stroke

Sponsor: The Florey Institute of Neuroscience and Mental Health

View on ClinicalTrials.gov

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

Interventions

DRUG

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