Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06372483
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-18
First Post:
2024-03-15
Brief Title:
Single Dose Trial of VMX-C001 in Healthy Subjects With and Without FXa Direct Oral Anticoagulant
Sponsor:
VarmX BV
Organization:
VarmX BV
Study Overview
Official Title:
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
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-507059-32-00 | CTIS | None | None |