SAN-300: Phase I data

Data from 66 healthy volunteers in a double-blind, placebo-controlled, Australian Phase I trial showed that single doses of IV and subcutaneous formulations of SAN-300 were generally well tolerated. The most common adverse events with IV administration were mild or moderate headaches and infusion reactions. The most common adverse events with subcutaneous administration were headaches and mild injection-site reactions. Subjects received placebo, 0.03-2 mg/kg doses of IV SAN-300 or 2-6 mg/kg doses of subcutaneous SAN-300. Additionally, a single patient with active RA who received 2 mg/kg IV SAN-300 achieved an ACR50 response at days 15 and 29 and a reduction in DAS28-CRP score of 1.66 points at day 15 and 0.92 points at day 29. A placebo-treated patient with active RA did not achieve an ACR20 or DAS28-CRP response at any time point. Data were presented at the American College of Rheumatology meeting in San Diego. ...