drugset / Trial / NCT05484154
Efficacy and Safety Evaluation of 3K3A-APC in Ischemic Stroke
Phase 3
Withdrawn
ZZ Biotech, LLC
National Institute of Neurological Disorders and Stroke (NINDS) · collabUniversity of Cincinnati · collabUniversity of South Carolina · collabUniversity of Southern California · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this study is to evaluate the efficacy and safety of intravenous doses of 3K3A-APC, a recombinant variant of human activated protein C (APC), in the treatment of acute ischemic stroke following treatment with thrombolysis, mechanical thrombectomy or both.
Timeline
- Start
- 2024-10
- Primary completion
- 2026-07
- Completion
- 2026-10
Outcome
Outcome not reported
Stopped (Business): “NIH funding suspension.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | 3K3A-APC | Protein / enzyme biologic | 10 mg | Intravenous |
| Comparator | 3K3A-APC | Protein / enzyme biologic | 15 mg | Intravenous |
| Comparator | 3K3A-APC | Protein / enzyme biologic | 30 mg | Intravenous |