Knee Osteoarthritis
Conditions
Interventions
Single ascending dose group:RGL-236
Multiple ascending dose group:RGL-236 or 0.9% Sodium Chloride Injection
Sponsors
Affiliated hospital of Nantong University
Eligibility
Sex/Gender
All
Age
40 Years to 75 Years
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following criteria to be enrolled in this study. 1. Subjects must be able to understand and communicate with the investigator, comply with study requirements, volunteer to participate in this study, and provide written informed consent. 2. Male or female subjects aged 40 to 75 years (inclusive). 3. Body mass index (BMI) = 4 points (total 10 points), and pain lasting for at least 4 weeks.
Exclusion criteria
Exclusion criteria: Subjects will not be eligible for this study if they meet any of the following criteria. 1. Kellgren-Lawrence (K-L) radiographic grade of 4 for osteoarthritis of the non-study knee. 2. Severe varus or valgus deformity of the study knee. 3. Administration of physical therapy such as electrotherapy, acupuncture, or similar treatments to the study knee within 4 weeks prior to screening. 4. Intra-articular administration of intermediate- or short-acting corticosteroids, sodium hyaluronate, anesthetic agents, or systemic glucocorticoid therapy to the study knee within 12 weeks prior to screening. 5. Intra-articular injection of platelet-rich plasma (PRP) or long-acting corticosteroids into the study knee within 6 months prior to screening. 6. Clinical evidence of moderate to severe inflammation in the study knee (i.e., redness, warmth, effusion) during the screening period or within 4 weeks prior to screening, or clinical indication for arthrocentesis of the study knee. 7. Previous intra-articular surgery of the study knee, or planned knee surgery during the trial period; arthroscopic debridement or partial meniscectomy performed more than 6 months prior to screening is permitted. 8. Knee instability of the study knee (including but not limited to post-traumatic or congenital laxity) or insufficient ligament reconstruction based on medical history and/or physical examination. 9. Other pathological conditions of the knee confirmed by clinical assessment or imaging, including subchondral insufficiency fracture, fracture (acute or subacute fracture within 6 months prior to screening) or bone contusion, osteonecrosis, malignant bone marrow infiltration, solid tumor, and/or patellofemoral dysplasia. 10. Local contraindications at the injection site of the study knee, such as open wounds, psoriatic lesions, local infection, etc.; or systemic diseases or conditions that, in the investigator's judgment, preclude knee injection, such as coagulation disorders, requirement for anticoagulant therapy, etc. 11. Use of central analgesics (e.g., tramadol), narcotic analgesics (e.g., morphine, pethidine, and other opioids) within 5 elimination half-lives of the respective drug or 2 weeks prior to screening, whichever is longer. 12. Other painful conditions that may confound the assessment of pain associated with knee osteoarthritis of the study knee, including systemic diseases potentially involving joints, neurological disorders, ipsilateral hip arthritis, localized pain caused by radicular lumbar compression, and any other painful conditions that may interfere with efficacy evaluation. 13. Other known joint or cartilage diseases at screening, autoimmune diseases with inflammatory arthritis (including but not limited to rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, systemic lupus erythematosus), crystal arthritis (gout, pseudogout arthritis), reactive arthritis, active acute or chronic knee infection or previous knee infection, systemic chondropathy, systemic connective tissue disease. 14. History of malignant tumor within the past 5 years, except for cured localized cancers such as localized basal cell carcinoma of the skin, thyroid cancer, etc. 15. Any known active infection, including skin infection at the injection site, knee infection, or infections that may impair the immune system (e.g., HIV infection, active HBV infection, active HCV infection, syphilis, etc.): (1) Active HBV infection: positive hepatitis B surface antigen (
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence and severity of adverse events (AEs), as well as other safety assessments (including changes from baseline in vital signs, physical examination, laboratory tests, electrocardiography, etc.); | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics;Positive rate, titer, and duration of antibodies;Changes in efficacy scores; | — |
Countries
China
Contacts
Public ContactPan Liu
Affiliated hospital of Nantong University
Outcome results
None listed