Phase 3 Study of SL1002 Injectable to Treat Knee Pain from Mild to Moderate Osteoarthritis in Adults Aged 40 and Older

What this Trial Is About

Researchers are studying the safety and effectiveness of SL1002 injectable solution for treating knee pain in adults with mild to moderate osteoarthritis of the knee. This randomized, double-blind, placebo-controlled Phase III trial compares a single dose of SL1002 against a placebo to better understand its impact on knee pain. Participants will receive either a single injection of SL1002 or a placebo normal saline in a randomized order. The study uses a quadruple masking method to keep participants and researchers unaware of treatment assignments. The treatment is given once, and the effects on knee pain are observed over a 12-week period. Throughout the study, participants will be evaluated regularly to measure changes in daily pain intensity while walking. Researchers will monitor safety, compliance, and response to treatment using pain questionnaires and diagnostic nerve blocks. The main outcome is the change in average daily pain from the start of the study to 12 weeks after treatment. The trial is sponsored by Saol Therapeutics Inc and will last from November 2025 to February 2027.

Phase III Study to Assess the Safety and Efficacy of SL1002 for Osteoarthritis Knee Pain