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

Conditions

• Osteoarthritis, Knee Pain

Eligibility Criteria

Sex

ALL

Age

35 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• SL-1002 — DRUG
  SL-1002 injectable solution
• Placebo — DRUG
  Matching placebo injectable solution

Study Details

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.

Key Dates

First listed

Jul 22, 2022

Start date

Jun 13, 2022

Status verified

Aug 2023

Primary completion

Jan 31, 2024

Completion

Jan 31, 2024

Study Design

Enrollment

132 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: SL-1002
  SL-1002 injectable solution, single dose
• Placebo Comparator: Matching placebo
  Matching placebo injectable solution

Primary Outcome Measure

Occurrence of treatment emergent adverse events (TEAEs) overall [ Time Frame: Time of study drug administration to end of study visit (day 168) ]

Locations (15)

Find similar trials in Greenwood Village, CO