A Single Ascending Dose Study to Assess the Safety and Pharmacokinetics of Intra-articular AVD275 Injection in Patients With Osteoarthritis of the Knee
This study aims to understand the safety, drug concentration and distribution of an intra-articular injectable formulation of celecoxib, AVD275, in patients with knee osteoarthritis. One single injection at three different doses of the drug will be studied in a sequential order, and each participant will be monitored for 24 weeks over ten clinical visits.
• Written consent to participate in the study; Willingness and ability to comply with the study procedures, visit schedules and follow verbal and written instructions
• Male or female: 20 years to 75 years of age
• Symptoms associated with OA of the knee for ≥6 months prior to screening (patient reported is acceptable); Knee OA may be unilateral or bilateral
• Currently meets ACR Criteria (clinical and radiological) for OA as follows:
‣ Knee pain
⁃ At least one of the following:
• Age \> 50 years
∙ Stiffness \< 30 minutes
∙ Crepitus
⁃ Osteophytes
• Kellgren-Lawrence (K-L) Grade 1-4 in the index knee based on X-ray performed during screening (locally read) within 6 months from screening
• Body mass index (BMI) ≤ 40 kg/m2
• Ambulatory and in good general health