drugset / Trial / NCT05363397
Safety and Tolerability of Adjunctive TBO-309 in Reperfusion for Stroke
Phase 2
Recruiting
80 enrolled
The Florey Institute of Neuroscience and Mental Health
Neuroscience Trials Australia · collab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |