Safety and Pharmacodynamics of GNSC-001 Intra-articular Injection for Knee Osteoarthritis (DONATELLO)

Key Inclusion Criteria: OA in at least one knee (the 'target knee'), confirmed using centrally read X-ray with a Kellgren-Lawrence (KL) score of 2 or 3 Western Ontario & McMaster University Osteoarthritis Index (WOMAC) pain score ≥ 20 (on a 50-point numerical rating scale) in the target knee during the seven days prior to Screening Persistent moderate to severe symptoms in the target knee, despite failure or intolerance of a 3-month trial of at least 2 conservative therapies (e.g., activity modification, weight loss, physical therapy, opioids, and anti-inflammatory medications, and injection of hyaluronic acid or steroids) Presence of synovial fluid on ultrasound and/or high likelihood of successful extraction of synovial fluid Negative pregnancy test at Screening and Baseline (women of childbearing potential [WOCBP]) Key Exclusion Criteria: Current or documented history of inflammatory arthritis (such as gout or rheumatoid arthritis), inflammation of connective tissue, or other immunological disease Any form of joint degeneration as part of another syndrome (e.g., Ehler's Danlos, Stickler syndrome, etc.) Surgery in the target knee within the 6 months prior to screening Previous partial or total joint replacement in target knee Significant and clinically evident malalignment of the target knee that would impact the subject's function, as determined by the Investigator Body mass index (BMI) > 38 kg/m2 Clinically significant abnormal laboratory values at Screening in laboratory parameters that in the opinion of the Investigator, could represent a potential risk to participant safety: Plans to have, elective surgery of other joints or spine or intra-articular injections in the target knee, within the next 12 months