drugset / Trial / NCT06372483
Single Dose Trial of VMX-C001 in Healthy Subjects with and Without FXa Direct Oral Anticoagulant
RandomizedParallel-groupQuadruple-blindTreatment
Summary
A single centre, double-blind, randomized, placebo-controlled single dose study to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of VMX-C001, conducted in two parts: Part 1: Single dose of VMX-C001 or placebo in healthy volunteers. Part 2: Single dose of VMX-C001 or placebo in combination with a selected factor 10a (FXa) direct oral anticoagulant (DOAC) in healthy older subjects.
Timeline
- Start
- 2024-02-21
- Primary completion
- 2024-08-07
- Completion
- 2026-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Apixaban | Small molecule | 5 mg | Oral |
| Subject | Edoxaban | Small molecule | 60 mg | Oral |
| Subject | Rivaroxaban | Other / unclassified | 20 mg | Oral |
| Subject | VMX-C001 | Protein / enzyme biologic | — | Intravenous |