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

Last updated: March 24, 2026
Sponsor: Saol Therapeutics Inc
Overall Status: Active - Recruiting

Phase

3

Condition

N/A

Treatment

SL1002

Normal Saline

Clinical Study ID

NCT07226258
SL-1010-02
  • Ages > 40
  • All Genders

Study Summary

A Randomized, Double-Blind, Placebo-Controlled, Single Dose Study to Assess the Safety and Efficacy of SL1002 for the Treatment of Knee Pain in Patients with Osteoarthritis of the Knee.

Eligibility Criteria

Inclusion

Inclusion Criteria includes:

  1. Male or female patients ≥ 40 years of age

  2. Body Mass Index (BMI) limits

  3. Chronic knee pain resulting from osteoarthritis

  4. Kellgren-Lawrence Grade 2 (mild) or Grade 3 (moderate)

  5. Baseline KOOS pain

  6. Patients taking baseline analgesics

  7. Diagnostic nerve block response

  8. Compliance with identified study requirements

Exclusion Criteria includes:

  1. Non-OA inflammatory arthritis

  2. Confounding elements

  3. Lower limb amputation.

  4. Specified alternate historic treatments

  5. Identified underlying physiologic or psychosocial conditions

  6. Patient Health Questionnaire

  7. Moderate to severe hepatic impairment

  8. Moderate to severe renal impairment

  9. Identifiable baseline medications

  10. Protocol compliance requirements

  11. Known allergies or hypersensitivity to identified agents

  12. Identified alcohol or drug abuse history

  13. Identified underlying physical exam findings: ECG abnormalities or vital sign abnormalities during study screening per investigator assessment

  14. Identified underlying abnormal laboratory results

Study Design

Total Participants: 150
Treatment Group(s): 2
Primary Treatment: SL1002
Phase: 3
Study Start date:
November 07, 2025
Estimated Completion Date:
February 28, 2027

Study Description

This is a randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of a single treatment of SL1002 compared to placebo for the treatment of knee pain associated with mild to moderate osteoarthritis.

Connect with a study center

  • Innovative Pain Treatment Solutions

    San Diego, California 92111
    United States

    Active - Recruiting

  • DBPS Research, LLC

    Greenwood Village, Colorado 80111
    United States

    Active - Recruiting

  • DBPS Research, LLC

    Greenwood Village 5423908, Colorado 5417618 80111
    United States

    Site Not Available

  • International Spine, Pain & Performance Center

    Washington D.C., District of Columbia 20006
    United States

    Active - Recruiting

  • International Spine, Pain & Performance Center

    Washington D.C. 4140963, District of Columbia 4138106 20006
    United States

    Site Not Available

  • Prime Medical Research

    Coral Gables, Florida 33134
    United States

    Active - Recruiting

  • Conquest Research, LLC

    Orlando, Florida 32832
    United States

    Active - Recruiting

  • Conquest Research, LLC

    Winter Park, Florida 32789
    United States

    Active - Recruiting

  • Prime Medical Research

    Coral Gables 4151871, Florida 4155751 33134
    United States

    Site Not Available

  • Conquest Research, LLC

    Orlando 4167147, Florida 4155751 32832
    United States

    Site Not Available

  • Conquest Research, LLC

    Winter Park 4178560, Florida 4155751 32789
    United States

    Site Not Available

  • Queen City Clinical Research, PLLC

    Charlotte, North Carolina 28211
    United States

    Active - Recruiting

  • The Center for Clinical Research

    Winston-Salem, North Carolina 27103
    United States

    Active - Recruiting

  • Queen City Clinical Research, PLLC

    Charlotte 4460243, North Carolina 4482348 28211
    United States

    Site Not Available

  • The Center for Clinical Research

    Winston-Salem 4499612, North Carolina 4482348 27103
    United States

    Site Not Available

  • Comprehensive Specialty Care

    Edmond, Oklahoma 73034
    United States

    Active - Recruiting

  • Pacific Sports and Spine

    Eugene, Oregon 97404
    United States

    Active - Recruiting

  • Pacific Sports and Spine

    Eugene 5725846, Oregon 5744337 97404
    United States

    Site Not Available

  • University Orthopedics Center

    Altoona, Pennsylvania 16602
    United States

    Active - Recruiting

  • Pain Diagnostics & Interventional Care LLC

    Sewickley, Pennsylvania 15143
    United States

    Active - Recruiting

  • University Orthopedics Center

    Altoona 5178195, Pennsylvania 6254927 16602
    United States

    Site Not Available

  • Medical University of South Carolina (MUSC)

    Charleston, South Carolina 29425
    United States

    Active - Recruiting

  • PCPMG Clinical Research Unit, LLC

    Greenville, South Carolina 29601
    United States

    Active - Recruiting

  • PCPMG Clinical Research Unit, LLC

    Greenville 4580543, South Carolina 4597040 29601
    United States

    Site Not Available

  • Legent Orthopedic and Spine Hospital

    Bellaire, Texas 77401
    United States

    Active - Recruiting

  • Institute of Precision Pain Medicine

    Corpus Christi, Texas 78414
    United States

    Active - Recruiting

  • International Spine, Pain & Performance Center (IPP)

    Tyler, Texas 75701
    United States

    Active - Recruiting

  • HD Research, First Surgical Hospital (FSH)

    Bellaire 4673353, Texas 4736286 77401
    United States

    Site Not Available

  • Institute of Precision Pain Medicine

    Corpus Christi 4683416, Texas 4736286 78414
    United States

    Site Not Available

  • Virginia iSpine Physicians, PC

    Richmond, Virginia 23238
    United States

    Active - Recruiting

  • Virginia iSpine Physicians, PC

    Richmond 4781708, Virginia 6254928 23238
    United States

    Site Not Available

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