Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: An Open Label Phase II Multiple Dose Safety, Pharmacokinetic and Pharmacodynamics Study of SEL-212 Followed by Open Label Administration of SEL-037 in Subjects With Symptomatic Gout and Elevated Blood
Brief Summary:
This is an open label multicenter study to evaluate the safety and tolerability of multiple doses(3 monthly IV infusions) of SEL-212 ( a combination of pegsiticase( SEL-037) and SVP-rapamycin (SEL-110)) followed by multiple doses (2 monthly IV infusions) of pegsiticase (SEL-037) alone for a total of 5 treatment cycles in subjects with symptomatic gout and hyperuricemia. Additional subjects will be treated with multiple doses( 5 monthly IV infusions) of pegsiticase (SEL-037) alone.
Subjects will be monitored for safety endpoints through the 5th treatment cycle plus 30 days .Pharmacokinetic samples will drawn a pre-determined time points in addition to weekly serum uric acid levels.