Recruiting
Phase 3

SL1002

Sponsor:

Saol Therapeutics Inc

Code:

NCT07226258

Conditions

Osteoarthritis Knee Pain

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Interventions

SL1002

Normal Saline

Study Details

Brief 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.

Conditions

Osteoarthritis Knee Pain

Study ID

NCT07226258

Start date

Nov 7, 2025

Status verified date

Aug, 2026

Completion date

Feb 28, 2027

Anticipated

Primary completion date

Nov 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

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

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: SL1002

SL1002

placebo comparator: Placebo

Normal saline

Interventions

SL1002

SL1002 injectable solution

Normal Saline

Normal Saline

Primary outcome measure

  • Change From Baseline to Week 12 in the Weekly Mean of the Average Daily Pain Intensity While Walking [ Time Frame: Baseline to week 12 ]

Central Contacts and Locations

Central contacts

Locations

Sutter Neurology and Pain Management

Recruiting

Roseville, California, United States, 95661

Contacts

Principal Investigator:

Samir Sheth, M.D.

Innovative Pain Treatment Solutions

Recruiting

San Diego, California, United States, 92111

Contacts

Krishnan Chakravarthy, M.D., Ph.D.

770-274-0827info@saolrx.com

Principal Investigator:

Krishnan Chakravarthy, M.D., Ph.D.

DBPS Research, LLC

Recruiting

Greenwood Village, Colorado, United States, 80111

Contacts

Scott Bainbridge, MD

770-274-0827info@saolrx.com

Principal Investigator:

Scott Bainbridge, M.D.

International Spine, Pain & Performance Center

Recruiting

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

Contacts

Principal Investigator:

Mehul Desai, M.D.

Prime Medical Research

Recruiting

Coral Gables, Florida, United States, 33134

Contacts

Miguel Telleria, M.D.

770-274-0827info@saolrx.com

Principal Investigator:

Miguel Telleria, M.D.

Conquest Research, LLC

Recruiting

Orlando, Florida, United States, 32832

Contacts

Principal Investigator:

Gilbert Mbeo, M.D.

Interventional Pain Institute

Recruiting

The Villages, Florida, United States, 32159

Contacts

Brent Compton, MD, DC, FACP

770-274-0827info@saolrx.com

Principal Investigator:

Brent Compton, MD, DC, FACP

Conquest Research, LLC

Recruiting

Winter Park, Florida, United States, 32789

Contacts

Principal Investigator:

Anand Patel, M.D.

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Principal Investigator:

Ryan D'Souza, M.D.

Queen City Clinical Research, PLLC

Recruiting

Charlotte, North Carolina, United States, 28211

Contacts

Christopher Gilmore, M.D.

770-274-0827info@saolrx.com

Principal Investigator:

Christopher Gilmore, M.D.

The Center for Clinical Research

Recruiting

Winston-Salem, North Carolina, United States, 27103

Contacts

Leonardo Kapural, MD

770-274-0827info@saolrx.com

Principal Investigator:

Leonardo Kapural, M.D.

Comprehensive Specialty Care

Recruiting

Edmond, Oklahoma, United States, 73034

Contacts

Douglas Beall, M.D.

770-274-0827info@saolrx.com

Principal Investigator:

Douglas Beall, M.D.

Pacific Sports and Spine

Recruiting

Eugene, Oregon, United States, 97404

Contacts

Gregory Moore, M.D.

770-274-0827info@saolrx.com

Principal Investigator:

Gregory Moore, M.D.

University Orthopedics Center

Recruiting

Altoona, Pennsylvania, United States, 16602

Contacts

Principal Investigator:

Fred Khalouf, D.O.

Pain Diagnostics & Interventional Care LLC

Recruiting

Sewickley, Pennsylvania, United States, 15143

Contacts

David Provenzano, M.D.

770-274-0827info@saolrx.com

Principal Investigator:

David Provenzano, M.D.

Medical University of South Carolina (MUSC)

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Principal Investigator:

Ameet Nagpal, M.D.

PCPMG Clinical Research Unit, LLC

Recruiting

Greenville, South Carolina, United States, 29601

Contacts

Brian Jakubowicz, M.D.

770-274-0827info@saolrx.com

Principal Investigator:

Brian Jakubowicz, M.D.

Legent Orthopedic and Spine Hospital

Recruiting

Bellaire, Texas, United States, 77401

Contacts

Daneshvari Solanki, MD

770-274-0827info@saolrx.com

Principal Investigator:

Daneshvari Solanki, M.D.

Institute of Precision Pain Medicine

Recruiting

Corpus Christi, Texas, United States, 78414

Contacts

Mitchell Engle, M.D.

770-274-0827info@saolrx.com

Principal Investigator:

Mitchell Engle, M.D.

International Spine, Pain & Performance Center (IPP)

Recruiting

Tyler, Texas, United States, 75701

Contacts

Aaron Calodney, M.D.

770-274-0827info@saolrx.com

Principal Investigator:

Aaron Calodney, M.D.

University of Utah Orthopedic Center

Recruiting

Salt Lake City, Utah, United States, 84108

Contacts

Zachary McCormick, M.D.

770-274-0827info@saolrx.com

Principal Investigator:

Zachary McCormick, M.D.

Virginia iSpine Physicians, PC

Recruiting

Richmond, Virginia, United States, 23238

Contacts

Michael DePalma, MD

770-274-0827info@saolrx.com

Principal Investigator:

Michael DePalma, M.D.

More Information

Sponsor

Saol Therapeutics Inc

Last update posted

Aug 25, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Saol Therapeutics Inc on 2026-08-25.