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Single Dose Trial of VMX-C001 in Healthy Subjects with and Without FXa Direct Oral Anticoagulant

NCT06372483 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-11-18

No results posted yet for this study

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.

Conditions

  • Coagulation Disorder

Interventions

DRUG

VMX-C001

VMX-C001 is human factor X engineered to be insensitive to factor Xa DOACs

DRUG

Placebo

VMX-C001 matched placebo

DRUG

Rivaroxaban 20 mg Oral Tablet

Fxa DOAC

DRUG

Apixaban 5 mg Oral Tablet

Fxa DOAC

DRUG

Edoxaban 60 mg Oral Tablet

Fxa DOAC

Sponsors & Collaborators

  • VarmX B.V.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2024-02-21
Primary Completion
2024-08-07
Completion
2026-08-31

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Drugs

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 NCT06372483 on ClinicalTrials.gov