NCT06517563

Effects of VMX-C001 on the Anticoagulant Effect of Different Forms of Heparin

An Open-Label Study to Assess the Effects of VMX-C001 in Combination With an Oral FXa DOAC on the Efficacy of Unfractionated Heparin and of VMX-C001 Alone on the Efficacy of Low Molecular Weight Heparin in Healthy Subjects

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (estimated)
• Sponsor: VarmX B.V. · Industry
• Sex: All
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

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.

Conditions

• Coagulation Disorder

Interventions

Type	Name	Description
DRUG	VMX-C001	VMX-C001 is human factor X engineered to be insensitive to factor Xa DOACs
DRUG	Rivaroxaban	FXa Inhibitor
DRUG	UFH	Unfractionated Heparin
DRUG	Enoxaparin	Low Molecular Weight Heparin

Timeline

• Start date: 2024-08-14
• Primary completion: 2024-12-09
• Completion: 2026-10-01
• First posted: 2024-07-24
• Last updated: 2025-09-10

Locations

1 site across 1 country: Netherlands