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

NCT06517563 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2026-05-11

No results posted yet for this study

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

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

Sponsors & Collaborators

  • VarmX B.V.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-08-14
Primary Completion
2024-12-09
Completion
2026-04-13

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06517563 on ClinicalTrials.gov