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

A Phase 1, Placebo-Controlled, Double-Blind, Dose-Escalation Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SM04690 Injected in the Target Knee Joint of Moderately to Severely Symptomatic Osteoarthritis Subjects

The purpose of this study is to find the optimal dose of SM04690 that can be safely given by intra-articular injection into the target knee joint of subjects with moderate to severe osteoarthritis.

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