NCT06372483

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

A Randomised, Double-Blind, Placebo-Controlled, Single Dose Trial Evaluating Different Doses of Intravenously Administered VMX-C001 and to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of VMX-C001 in Healthy Subjects (Part 1) and in Combination with a Selected FXa Direct Oral Anticoagulant (DOAC) in Healthy Older Subjects (Part 2)

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: VarmX B.V. · Industry
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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

Timeline

• Start date: 2024-02-21
• Primary completion: 2024-08-07
• Completion: 2026-08-01
• First posted: 2024-04-18
• Last updated: 2024-11-18

Locations

1 site across 1 country: Netherlands