drugset / Trial / NCT06517563
Effects of VMX-C001 on the Anticoagulant Effect of Different Forms of Heparin
Non-randomizedParallel-groupOpen-labelTreatment
Summary
A single centre, open-label study to assess the effects of VMX-C001 in combination with an oral FXa DOAC on the efficacy of Unfractionated Heparin (UFH) and of VMX-C001 alone on the efficacy of Low Molecular Weight Heparin (LMWH) in healthy subjects conducted in two parts: UFH cohort: Subjects will be administered 2 single doses of 5000 IU UFH i.v. on Day 1 and Day 5, oral doses of the DOAC Rivaroxaban once daily from Day 2 until the morning of Day 5, and one single dose of 170 mg VMX-C001 i.v. on Day 5. LMWH cohort: Subjects will be administered 2 single doses of 40 mg Enoxaparin s.c. on Day 1 and Day 4, and one single dose of 170 mg VMX-C001 i.v. on Day 4.
Timeline
- Start
- 2024-08-14
- Primary completion
- 2024-12-09
- Completion
- 2026-04-13
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Enoxaparin sodium | Other / unclassified | 40 mg | Subcutaneous |
| Subject | Heparin | Other / unclassified | 5000 iu | Intravenous |
| Subject | VMX-C001 | Protein / enzyme biologic | 170 mg | Intravenous |
| Background | Rivaroxaban | Other / unclassified | — | Oral |