An Open Label Phase IIb Study to Evaluate Safety and Tolerability of OA-SYS in Subjects With Moderate to Severe Osteoarthritis of the Knee Joint
This study is being conducted to evaluate the safety and tolerability of OA-SYS in patients with moderate to severe OA of the knee joint.
• Adults between the ages of 35 - 75 years Body Mass Index (BMI) less than 39 kg/m2
• Ambulatory and in good general health
• Willing and able to comply with the study procedures and visit schedules and able to follow verbal and written instructions
• Willing to abstain from use of protocol-restricted treatments from Screening through End-of-Treatment
• Kellgren-Lawrence grading scale score of 3 or 4 for OA of the knee
• No clinically significant abnormalities observed in medical history, physical exam vital signs, and laboratory assessments
• For females of reproductive potential: use of effective contraception for at least 1 month prior to screening and agreement to use such a method till end of the study period and negative pregnancy test
• For males of reproductive potential: use of condoms and other methods to ensure effective contraception