drugset / Trial / NCT05152420
Study of Intravenous VMX-C001 in Healthy Subjects and in Combination With Selected Direct Oral Anticoagulants in Healthy Older Subjects
RandomizedParallel-groupQuadruple-blindTreatment
Summary
A single centre, double-blind, randomized, parallel group, placebo-controlled study in healthy subjects conducted in two parts: Part 1: Single ascending doses in healthy subjects aged 18 to 49 years to assess safety, pharmacokinetics (PK) and pharmacodynamic (PD) effects of VMX-C001. Part 2: Healthy subjects aged 50 to 79 years to assess safety, PK and PD effects of VMX-C001 in the presence of DOACs.
Timeline
- Start
- 2021-10-29
- Primary completion
- 2023-02-03
- Completion
- 2023-02-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | VMX-C001 | Protein / enzyme biologic | — | Intravenous |
| Background | Apixaban | Small molecule | — | — |
| Background | Edoxaban | Small molecule | — | — |
| Background | Rivaroxaban | Other / unclassified | — | — |