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.
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
n/a
| NCT number | NCT05205863 |
| Study type | Interventional |
| Source | Prothya Biosolutions |
| Contact | Vladislava Zamfirova, MD |
| Phone | +1-410-2364368 |
| [email protected] | |
| Status | Recruiting |
| Phase | Phase 1/Phase 2 |
| Start date | November 26, 2021 |
| Completion date | December 2022 |
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