Phase 1, Dose Escalation Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SM04690 in Moderate to Severe Knee Osteoarthritis (OA)

Inclusion Criteria: * Diagnosed with primary OA in target knee by American College of Rheumatology (ACR) criteria * Screening pain criteria sufficient as assessed by WOMAC and VAS scores * Ability to read and understand the informed consent Exclusion Criteria: * Women who are pregnant or lactating or child bearing potential, men must use a barrier method of contraception * Any condition, including laboratory findings, that in the opinion of the investigator constitutes a risk or contraindication for participation in the study or that could interfere with the study objectives, conduct or evaluation * Body mass index \>40 * Major knee surgery in the target knee within 12 months prior to study or planned surgery during the study period * History of malignancy within the last 5 years * Participation in a clinical research trial within 12 weeks prior * Treatment of the target knee with intra-articular steroids within 2 months or hyaluronic acid derivatives within 6 months * Effusion of the target knee requiring aspiration within 3 months * Use of electrotherapy or acupuncture for OA within 4 weeks * Significant and clinically evident misalignment of the target knee * Any known active infections * Any chronic condition that has not been well controlled for a minimum of 3 months