A Multicenter, Randomized, Open-Label, Blinded Endpoint Evaluation, Active Controlled Study to Compare the Efficacy and Safety of SRSD107 and Enoxaparin in Adult Subjects Undergoing Elective Primary Unilateral Total Knee Arthroplasty
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.
• Willing to comply with study requirements including taking study drug at least 28 days prior to TKA, clinic visits, and venography at 10-14 days post TKA.
• aPTT, PT, and INR within the normal reference range at screening.