Randomized, Doube-blind, placebo-controlled, single dose of UBX0101 in moderate to severe, painful osteoarthritis of the knee
Criteria:1. Patients who are ambulatory with a dignosis of OA of te knee, as defined by the American College of Rhuematology (ACR) criteria and who have a baseline pain with a mean of >4 and >9 on the 11 poont (0-10) average daily pain NRS for at least five of seven days during the sceening period.
2. Patients with a KL grade of 1-4 based on central reading of a weight-bearing radiograph ot target knee.
3. Patients ages 40-85
4. Patients are permitted but not required to use an oral NSAID, serotonin, and nonrepinephrine reuptake inhibitators (SNRIs) such as Cymbalta (duloxetine), tramadol, or acetaminophen, provided that they have been taking a stable dose and regimen of medication for at least 4 weeks prior to screening
5. Patients with type 2 diabetes mellitus can be included as long as they are under adequate control and have no evidence or history of diabetic neuropathy
6. Patients who have the capacity to give informed consent and who are willing and able to comply with all study - related procedures and assesments. Patients who do not have the legal capacity or medical competency to give written informed consent are ineligbile for this study.