This is a Phase 2, multicenter, randomized, open-label, parallel group, blinded endpoint evaluation, active-controlled, dose-finding study.This study is designed to compare the efficacy and safety of 3 dose levels of SRSD107 and enoxaparin 40 mg daily in subjects undergoing elective primary unilateral TKA.
Able to provide written informed consent before any study assessment is performed.
Male and female subjects, of any race, between 60 and 80 years of age, inclusive.
Body mass index between 18.0 and 35.0 kg/m2, inclusive.
Eligible to undergo elective primary unilateral TKA under general anesthesia.
Active bleeding requiring medical or surgical intervention within 4 weeks prior to screening.
Known bleeding disorder; history of increased bleeding tendency or any other condition that in the opinion of the investigator contraindicates prophylactic anticoagulation.
History of intracranial, intraspinal, or intraocular bleeding.
Evidence of active cancer, or a history of malignancy, within 2 years prior to screening.