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Dose-Response in PD and Safety of Cofact Under VKA Anticoagulation

Healthy Volunteers Clinical Trial

Official title:
A Phase 1/2 Study of the Dose-Response in Pharmacodynamics and Safety of Prothrombin Complex Concentrate Cofact in Healthy Subjects Under Vitamin K Antagonist Anticoagulation.

Clinical Trial Summary

This is a randomized, open label, placebo-controlled, parallel design, single center, prospective study. Subjects will receive treatment with VKA. Subjects who reach the targeted INR, will receive single dose of Cofact. Multiple coagulation laboratory tests will be evaluated over a period of 15 days

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05205863
Study type Interventional
Source Prothya Biosolutions
Contact Vladislava Zamfirova, MD
Phone +1-410-2364368
Email vladislava.zamfirova@prothya.com
Status Recruiting
Phase Phase 1/Phase 2
Start date November 26, 2021
Completion date December 2022
View Details
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