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

Prothya Biosolutions

Status and phase

Completed

Phase 2

Phase 1

Conditions

Healthy Volunteers

Treatments

Biological: Cofact

Study type

Interventional

Funder types

Industry

Identifiers

NCT05205863

MD2021.01

Details and patient eligibility

About

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

Enrollment

69 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Male or female of nonchildbearing potential.
Healthy subjects.

Exclusion criteria

Evidence of coagulation disturbances, or disposition for thrombo-embolic events
Liver function tests more than 1.2 times the upper normal limits
Participants with thyroid disorders as evidenced by assessment of TSH levels outside the normal reference range at screening.
Prior history of thromboembolic complications including those in first degree relatives.
Glomerular filtration rate (GFR) is lower than estimated GFR 62 mL/min/1.73 m2 using the Modification of Diet in Renal Disease Study equation.
Anaphylactic or systemic reactions to human plasma, plasma products, or blood products.
History of hypersensitivity to active or inactive excipients of VKA
Gastrointestinal disease that may impair VKA absorption..
Participation in another clinical study <30 days prior to study entry.
Any clinically significant history of or current clinically significant disease or disorder as judged by the Investigator.
Positive nasopharyngeal PCR test for SARS-CoV-2 on Day -11 or Day -1.
Positive pregnancy test at screening, Day -11, or Day -1.