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Study of Intravenous VMX-C001 in Healthy Subjects and in Combination With Selected Direct Oral Anticoagulants in Healthy Older Subjects

NCT05152420 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2023-06-02

No results posted yet for this study

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.

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

Apixaban

FXa Inhibitor

DRUG

Rivaroxaban

FXa Inhibitor

DRUG

Edoxaban

FXa Inhibitor

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
2021-10-29
Primary Completion
2023-02-03
Completion
2023-02-03

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 NCT05152420 on ClinicalTrials.gov