A 4-week Study to Evaluate the Efficacy and Safety of HP-5000 in Subjects With Knee Osteoarthritis

This is a multicenter, randomized, double-blind, and placebo-controlled phase 2 study
evaluating 2 formulations of HP-5000 in subjects with OA of the knee. The study will consist
of up to 28-day Screening Phase that will include a Washout Period of current prescription
and over the counter (OTC) analgesics, a 4-week double-blind Treatment Phase, and a 1-week
safety Follow-up Period.

Inclusion Criteria:

- Male or female aged 40 to 85 years with a clinical diagnosis of OA of the target knee
according to the American College of Rheumatology (ACR) criteria, including:

- Symptoms for at least 6 months prior to screening, AND

- Knee pain in the target knee for 30 days of the preceding month (periarticular knee
pain due to OA and not due to other conditions such as bursitis, tendonitis, etc.) AND

- The pain in the target knee required the use of nonsteroidal anti-inflammatory drugs
(NSAIDs) either over the counter (OTC) per recommendation of a physician or
prescribed.

Exclusion Criteria:

- Body mass index (BMI) > 40

- Any subject who disobeyed the restriction of prohibited therapies (i.e., use rescue
medication) during Screening Washout Period.

- Secondary OA of the knee (rheumatoid arthritis, gout, psoriasis, syphilitic
neuropathy, ochronosis, metabolic or other primary bone disease or acute trauma).