Multi-Dose Safety/Pharmacodynamic Study of SEL-212/SEL-037 in Subjects With Symptomatic Gout & Elevated Blood Uric Acid
Status:
Completed
Trial end date:
2019-01-01
Target enrollment:
Participant gender:
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.