NCT05470608

Phase II Study to Assess Safety and Efficacy of SL-1002 for Osteoarthritic Knee Pain

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending Dose Escalation Study to Assess the Safety and Efficacy of SL-1002 Injectable for Treatment of Knee Pain Associated With Osteoarthritis

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 132 (estimated)
• Sponsor: Saol Therapeutics Inc · Industry
• Sex: All
• Age: 35 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Osteoarthritis, Knee Pain

Interventions

Type	Name	Description
DRUG	SL-1002	SL-1002 injectable solution
DRUG	Placebo	Matching placebo injectable solution

Timeline

• Start date: 2022-06-13
• Primary completion: 2024-01-01
• Completion: 2024-01-01
• First posted: 2022-07-22
• Last updated: 2023-08-29

Locations

15 sites across 1 country: United States

Regulatory

• FDA-regulated drug study