Phase II Study to Assess Safety and Efficacy of SL-1002 for Osteoarthritic Knee Pain
Status:
Recruiting
Trial end date:
2024-01-01
Target enrollment:
Participant gender:
Summary
This is a multicenter, randomized, double-blind, placebo-controlled, single ascending dose
escalation study to assess the safety and efficacy of single treatment exposure of an
injectable formulation of SL-1002 for the treatment of knee pain associated with
osteoarthritis. Phase A of the study will enroll 3 cohorts of 8 patients per cohort, for a
total of 24 patients. Patients will be randomized to receive either SL-1002 or placebo in a
3:1 ratio within each given cohort. Phase B of the study will enroll a minimum of 92 up to a
maximum of 108 patients. Patients will be randomized to receive either SL-1002 or placebo in
a 3:1 ratio at the recommended dose determined from Phase A. The study period will be up to
168 days inclusive of a screening period of up to 28 days.