Safety and Efficacy Study of 4975 in Patients Undergoing Total Knee Replacement

A Phase 3, Multicenter, Randomized, Placebo-Controlled, Parallel-Group, Double-Blind Study to Evaluate the Efficacy, Tolerability, Safety, and Pharmacokinetics of 4975 in Patients Undergoing Primary Unilateral Total Knee Arthroplasty

Evaluate the efficacy, tolerability, safety, and pharmacokinetics of 4975 in patients undergoing total knee replacement

The purpose of this study is to evaluate the efficacy, tolerability, safety, and pharmacokinetics of 4975 in patients undergoing primary unilateral total knee arthroplasty

Key Inclusion Criteria:

• Male or female aged 18 to 85 years with an American Society of Anesthesiologists (ASA) status of I, II, or III
• Planning to undergo primary unilateral Total Knee Arthroplasty (TKA)

Key Exclusion Criteria:

• A body mass index (BMI) greater than 43
• Known bleeding disorder or is taking agents affecting coagulation preoperatively
• Use of medications or a medical condition that in the investigator's opinion could adversely impact the patient's participation or safety, conduct of the study, or interfere with the pain assessments
• Diabetes mellitus with a known HbA1C>9.5 or a history of prolonged uncontrolled diabetes
• Previous knee arthroplasty (partial or total) of the same knee
• Participated in another clinical trial within 30 days prior to the planned TKA surgery