Gouty Arthritis
Conditions
Interventions
UA007 Group:Subjects were administered UA007 90 mg (prepared with 3 ml of sterile water for injection) with a single intramuscular (gluteus maximus) injection
placebo group:Subjects were given 3 ml of placebo saline with a single intramuscular (gluteus maximus) injection.
Sponsors
Zhongshan Hospital Affiliated to Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age is 18-65 years old, gender is not limited; 2. Weight >= 50kg, and BMI is in the range of 19-28kg/m^2, including both ends; 3. Meets the diagnostic criteria for gouty arthritis and is in the intermittent period. See ACR/EULAR 2015 Gout Classification Criteria (see Appendix 1); 4. Willingness to use non-hormonal contraception during the study; 5. Understand and voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Allergic to the study drug or any ingredient in the study drug, or allergic to the constitution; 2. Before administration of the test drug, any of the following drugs or treatments were used: 1) those who received drug therapy with a similar structure or mechanism of the study drug (such as TNF-a, IL-1ß, IL-6 inhibitors) within 1 month before administration; 2) those who used drugs known to have strong immunosuppressive or immunomodulatory effects (such as tacrolimus, tripterygium, glucocorticoid, etc.) within 3 months before administration; 3) those who smoked, drank alcohol, or ate foods and beverages containing high purine or caffeine; strenuous exercise; or those who had other factors affecting drug absorption, distribution, metabolism, excretion, etc.; 4) the subjects did not take uric acid lowering drugs (phenylbromide) before administration Malone, allopurinol, febustat, etc.), and plan to use it during the study period; those who take uric acid lowering drugs before administration, cannot be used stably for at least 1 month and the blood uric acid cannot be in a stable period; or those who experience an acute attack of gout within 1 month; 5) Those who use colchicine and nonsteroidal anti-inflammatory drugs (NSAIDs) within 1 month before administration to treat or prevent an acute attack of gout; 3. A history or evidence of any of the following conditions: 1) any systemic inflammatory disease other than gout, including but not limited to systemic lupus erythematosus, juvenile chronic arthritis, spondyloarthropathy, Crohn's disease, ulcerative colitis, psoriatic arthritis, active vasculitis; 2) a history of decompensated heart failure (New York Heart Association classification III and IV), unstable angina pectoris, stroke or transient ischemic attack, myocardial infarction, persistent and clinically significant arrhythmia, coronary artery bypass grafting or percutaneous coronary intervention; 3) a history of malignancy or hematologic malignancy; 4) a history of malignancy within 3 months prior to administration Have received a live vaccine or been to an affected area; 5) Symptomatic herpes simplex at the time of screening; 6) Have a history of tuberculosis (TB), or have family contact with an active TB patient who has not received appropriate and documented TB prophylaxis; 7) Have blood cachexia or any disease that can cause hemolysis or red blood cell instability; 8) Have active or recurrent peptic ulcer; 9) Have undergone major surgery within 1 month before administration and the investigator does not consider it suitable to receive the test drug; 10) Donate blood >= 400 ml within 3 months before administration; 11) Have participated in a clinical trial of any drug or medical apparatus before administration (including placebo group) The end of the study did not exceed 30 days, or did not exceed the 5 half-lives of the study drug (using 30 days and the longer of the 5 half-lives); 12) Infectious diseases and systemic antibiotic treatment within 2 weeks before administration; 13) Severe mental or nervous system diseases; 14) Secondary gout caused by various reasons, including but not limited to the following: cell proliferation diseases, including leukemia, lymphoma, myeloma, polycythemia and other primary diseases; cell destructive diseases, including hemolysis, burns, trauma, chemotherapy, radiotherapy, excessive exercise and other reasons; hypertensive nephropathy, chronic nephritis, vasculitic nephritis, diabetic nephropat
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics; | — |
Countries
china
Contacts
Public ContactLindi Jiang
Zhongshan Hospital Affiliated to Fudan University
Outcome results
None listed