NCT05152420

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

A Randomised, Double-Blind, Placebo-Controlled, Single Ascending Dose Trial to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenously Administered VMX-C001 in Healthy Subjects (Part 1) and in Combination With Selected Direct Oral Anticoagulants (DOACs) in Healthy Older Subjects (Part 2)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: VarmX B.V. · Industry
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Accepted

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

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	Apixaban	FXa Inhibitor
DRUG	Rivaroxaban	FXa Inhibitor
DRUG	Edoxaban	FXa Inhibitor

Timeline

• Start date: 2021-10-29
• Primary completion: 2023-02-03
• Completion: 2023-02-03
• First posted: 2021-12-09
• Last updated: 2023-06-02

Locations

1 site across 1 country: Netherlands