drugset / Trial / NCT05363397

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

NCT05363397 ↗

Non-randomizedSequentialSingle-blindTreatment

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.

Timeline

Start
2023-09-27
Primary completion
2026-02-01
Completion
2026-05-01

Drugs

EvaluationDrugModalityDoseRoute
Subject TBO-309 Unknown 30 mg Intravenous
Subject TBO-309 Unknown 60 mg Intravenous
Subject TBO-309 Unknown 120 mg Intravenous
Subject TBO-309 Unknown 180 mg Intravenous

Indications