Knee Osteoarthritis
Conditions
Interventions
SAD:Different doses of K11/placebo for injection
MAD:Different doses of K11/placebo for injection
Sponsors
Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine
Eligibility
Sex/Gender
All
Age
24 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. 24-75 years old (including the cut-off value), regardless of gender; 2. Body mass index (BMI) in the range of 18.0-30.0 kg/m2 (including the cut-off value); 3. According to the American rheumatism association standard (clinical and radiological criteria, see appendix 6), decide the aim of diagnosis of the knee joint of primary shares or tibial arthritis for at least six months after a routine clinical treatment, such as hormones, opioids, such as viscoelastic supplementation, after discontinuation knee osteoarthritis patients with recurrence or aggravate again; 4. The target knee was grade ? or ? according to the Kellgren-Lawrence scale of knee osteoarthritis (in the case of bilateral knee osteoarthritis, the target knee was determined by the investigator based on radiographs and the subject's WOMAC pain score); 5. No planned knee surgery (e.g., partial or total knee replacement, interventional arthroscopy) was performed within 6 months after the initial injection of the study drug; 6. At baseline, the VAS score for WOMAC pain score 1 (A1) of the target knee was between 40 and 80 mm (total 100 mm), and chronic pain had persisted for at least 4 weeks since the informed consent was signed; 7. The subject (or his/her sexual partner) has no pregnancy plan during and within 6 months after the end of the trial, voluntarily takes effective physical contraception measures, and has no sperm or egg donation plan; 8. Sign the informed consent voluntarily, have good communication with the researchers, and understand and comply with the requirements of the study.
Exclusion criteria
Exclusion criteria: 1. Known or suspected allergic history or serious adverse reactions to the study drug and its excipients, or allergic constitution; 2. Severe heart disease (NYHA cardiac function grade ? or above) and abnormal liver function 3. Candidates who have received clinical trials of other drugs within 3 months before screening; 4. Patients who had received any drug injection in the lumen of the knee joint (bilateral or either side) in the previous 6 months were screened; 5. Start use of drugs or foods (glucosamine, chondroitin sulfate, bisacarine, or avocado/soybean extract) with potential disease relief within 8 weeks before screening; If glucosamine, chondroitin sulfate, bisacarine, or avocado/soybean extract had been used =8 weeks prior to screening, steady doses were continued during the study; 6. Receive joint (bilateral or either side) physiotherapy or use Chinese patent medicine for knee osteoarthritis (bilateral or either side) within 6 weeks before the start of treatment; 7. Patients who received local injection of glucocorticoids or anesthetics in the knee joint (bilateral or either side) within 12 weeks before the start of treatment, or local topical glucocorticoids in the knee joint (bilateral or either side), or who required systemic glucocorticoids during the study; 8. Use of systemic corticosteroids within 12 weeks prior to screening; 9. Cannot suspend the use of analgesics during the study;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Security; | — |
Secondary
| Measure | Time frame |
|---|---|
| Womac; | — |
Countries
China
Contacts
Public ContactJie Zhao
Outcome results
None listed