A Study Evaluating the Safety, Tolerability, and Range of Biologically Active Doses of ICM-203 in Mild to Moderate Knee Osteoarthritis

Ki vehet részt

• Body Mass Index (BMI) of 18.0 to 40.0 kg/m2, inclusive, at the time of screening
• Kellgren-Lawrence grade 2 or grade 3 OA of target knee
• Target knee pain between 4 and 9, inclusive, on an NRS ranging from 0 (no pain) to 10 (worst pain imaginable)
• KOOS function in daily living score >25, a measure of knee function ranging from 0 (extreme problems) to 100 (no problems)
• A stable treatment regimen for symptomatic relief of OA, including NSAIDs, for 4 weeks prior to screening

Ki nem vehet részt

• Injection of steroid, hyaluronate or other agent, into the target knee less than 90 days prior to day 1
• Surgery on the target knee within 180 days prior to day 1
• Total knee arthroplasty or other knee surgery planned in the next 12 months
• Active joint infection or other concurrent medical (diabetes, uncontrolled hypertension, severe osteoporosis, glaucoma) or psychiatric condition that, in the opinion of the Investigator, would make the subject unsuitable for the study
• History of rheumatoid arthritis, psoriatic arthritis, gout, pseudogout, autoimmune OA, chondrocalcinosis, hemochromatosis, villonodular synovitis, and synovial chondromatosis or other disorder that in the opinion of the Investigator could cause inflammation of the knee
• Major injury to the target knee, such as torn ligament or severe sprain, within 12 months of screening
• Disability so severe that the subject cannot comply with the study requirements, including knee symptoms that result in significant difficulty or inability to walk