RecruitingPhase 3NCT07226258
Phase III Study to Assess the Safety and Efficacy of SL1002 for Osteoarthritis Knee Pain
A Randomized, Double-Blind, Placebo-Controlled, Single Dose Study to Assess the Safety and Efficacy of SL1002 Injectable for the Treatment of Knee Pain in Patients With Osteoarthritis of the Knee
Sponsor
Saol Therapeutics Inc
Enrollment
150 participants
Start Date
Nov 7, 2025
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 40 Years
Inclusion Criteria8
- Male or female patients ≥ 40 years of age
- Body Mass Index (BMI) limits
- Chronic knee pain resulting from osteoarthritis
- Kellgren-Lawrence Grade 2 (mild) or Grade 3 (moderate)
- Baseline KOOS pain
- Patients taking baseline analgesics
- Diagnostic nerve block response
- Compliance with identified study requirements
Exclusion Criteria14
- Non-OA inflammatory arthritis
- Confounding elements
- Lower limb amputation.
- Specified alternate historic treatments
- Identified underlying physiologic or psychosocial conditions
- Patient Health Questionnaire
- Moderate to severe hepatic impairment
- Moderate to severe renal impairment
- Identifiable baseline medications
- Protocol compliance requirements
- Known allergies or hypersensitivity to identified agents
- Identified alcohol or drug abuse history
- Identified underlying physical exam findings: ECG abnormalities or vital sign abnormalities during study screening per investigator assessment
- Identified underlying abnormal laboratory results
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Interventions
DRUGSL1002
SL1002 injectable solution
DRUGNormal Saline
Normal Saline
Locations(18)
View Full Details on ClinicalTrials.gov
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NCT07226258