A Study to Compare the Efficacy and Safety of SRSD107 and Enoxaparin in Adult Subjects Undergoing TKA
This study tests a new blood clot prevention medication called SRSD107 compared to a standard treatment (enoxaparin) in patients having knee replacement surgery. The research will evaluate how well SRSD107 works and how safe it is at different dose levels.
Key Objective: The trial is testing whether SRSD107 can effectively prevent dangerous blood clots after knee replacement surgery with a potentially safer or more convenient treatment option.
Who to Consider: Adults scheduled to undergo elective total knee replacement surgery who are willing to receive injected blood clot prevention medication should consider enrolling.
Trial Parameters
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Able to provide written informed consent before any study assessment is performed. 2. Male and female subjects, of any race, between 60 and 80 years of age, inclusive. 3. Body mass index between 18.0 and 35.0 kg/m2, inclusive. 4. Eligible to undergo elective primary unilateral TKA under general anesthesia. 5. 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. 6. aPTT, PT, and INR within the normal reference range at screening. Exclusion Criteria: 1. Active bleeding requiring medical or surgical intervention within 4 weeks prior to screening. 2. Known bleeding disorder; history of increased bleeding tendency or any other condition that in the opinion of the investigator contraindicates prophylactic anticoagulation. 3. History of intracranial, intraspinal, or intraocular bleeding. 4. Evidence of active cancer, or a history of malignancy, within 2 years prior to s