Dose-Response in PD and Safety of Cofact Under VKA Anticoagulation
Phase 1
Completed
- Conditions
- Healthy Volunteers
- Interventions
- Biological: Cofact
- Registration Number
- NCT05205863
- Lead Sponsor
- Prothya Biosolutions
- Brief 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 69
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cofact Dose 2 Cofact - Placebo Cofact - Cofact Dose 1 Cofact -
- Primary Outcome Measures
Name Time Method Peak thrombin generation at 30 minutes after end of the Cofact infusion 30 minutes post Cofact infusion
- Secondary Outcome Measures
Name Time Method Safety outcome up to Day 15 Frequency and severity of adverse events (AEs)
Changes in ETP 24 hours post Cofact infusion Change in endogenous thrombin potential (ETP) over 24 hours after the EOI
Coagulation markers up to Day 15 Concentration over time of clotting factors: FII, FVII, FIX, FX, protein C, and protein S
Concentration in clotting factors up to Day 15 Changes in aPTT, PT, and INR
Coagulation activation markers up to Day 15 Concentration over time of Prothrombin fragment 1+2, D-dimer, and thrombin-antithrombin complexes (TATs)
Trial Locations
- Locations (1)
PRA Health Sciences
🇳🇱Groningen, Netherlands