Knee osteoarthritis
Conditions
Interventions
Increase the dose of single-drug treatment:Bayesian optimal interval (BOIN) design was adopted to guide dose escalation
Sponsors
Affiliated Hospital of Nantong University
Eligibility
Sex/Gender
All
Age
55 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The subjects must be able to understand and communicate with the researchers, comply with the research requirements, and must provide a signed and dated written informed consent form before any research evaluation is conducted. Men and women aged 55 to 75 (including both ends). 3. Body Mass Index (BMI) = 5 points (a total of 10 points).
Exclusion criteria
Exclusion criteria: 1.The K-L radiological grade of knee osteoarthritis on the non-study side was grade 4. 2. Study severe genu varum/valgus deformity of the knee joint on the research side. 3. Within 4 weeks before screening, treatments such as electrotherapy, acupuncture, and intra-articular injection of sodium hyaluronate on the study side of the knee joint should be carried out. Or, medium and short-acting corticosteroid hormones or other drugs were injected into the knee cavity of the study side within 3 months before screening, or platelet-rich plasma or long-acting corticosteroid hormones were injected into the joint cavity within 6 months before screening. 4. Within 4 weeks before screening or during the screening period, there were clinical manifestations of moderate to severe inflammation in the knee joint of the study side (i.e., redness, fever, and effusion). 5. Has previously undergone surgery in the lumen of the knee joint on the study side or plans to perform knee joint surgery during the trial period. 6. There are other pathological manifestations of the knee joint confirmed by clinical assessment or imaging, including subchondral incomplete fractures, fractures (acute or subacute fractures within 6 months prior to screening), bone contusion, osteonecrosis, malignant bone marrow infiltration, solid tumors and/or patellofemoral dysplasia. 7. There are contraindications for local injection at the injection site of the knee joint on the study side, such as open trauma, psoriasis lesions, local infections, etc. Or systemic diseases or conditions that researchers determine cannot be used for knee joint injection, such as coagulation disorders (hemophilia, von Wille-Brandder's disease, factor X deficiency, etc.), and those requiring anticoagulant therapy, etc. 8. There are other pain conditions that may confuse the assessment of knee osteoarthritis-related pain, such as: systemic diseases that may involve the joint, neurological diseases, Paget's disease involving the knee joint, local pain caused by lumbar compression of radiculopathy type, and any other pain conditions that may confuse the assessment of effectiveness; Or use central analgesics (such as tramadol), narcotic analgesics (such as morphine, pethidine and other opioids), etc. within the first five drug half-lives or within two weeks before the screening period. 9. Other joint or cartilage diseases were known during screening. Autoimmune diseases with inflammatory arthritis (including but not limited to rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, systemic lupus erythematosus), crystalline arthritis (gout, pseudo-gouty arthritis), reactive arthritis, active acute or chronic knee joint infection or previous knee joint infection, systemic cartilage diseases, systemic connective tissue diseases. 10. At the time of screening, there is a history of malignant tumors in the past, or a history of malignant tumors in any organ system. 11. It is known that there are any active infections, including skin infections at the injection site or knee joint infections or infections that may damage the immune system (such as HIV infection or active HBV infection or HCV infection or syphilis, etc.). Active HBV infection: Positive hepatitis B surface antigen (HbsAg) at screening and HBV-DNA viral load greater than the upper limit of the normal reference range of local medical institutions. 12. Abnormal laboratory tests: Hemoglobin < 80 g/L or platelets < 100×10^9/L; 2) A
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The safety and tolerance of RGL-236; | — |
Secondary
| Measure | Time frame |
|---|---|
| The pharmacokinetic (PK) characteristics of RGL-236;The immunogenicity of RGL-236; | — |
Countries
China
Contacts
Public ContactFan Liu
Affiliated Hospital of Nantong University
Outcome results
None listed