Gouty Arthritis
Conditions
Interventions
1:UA007
Sponsors
Zhongshan Hospital Affiliated to Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Male and female aged 18-65 years (inclusive); 2. Body weight >= 50 kg and BMI= 50 mm; 7. Willing to use adequate contraception during study period; 8. Signed Informed consent.
Exclusion criteria
Exclusion criteria: 1. Allergic to the study drug or any component of the study drug or tend to allergy; 2. Use of specified pain relief medications (including NSAIDs, colchicine, glucocorticoids, narcotics such as opioid and Tramadol) within 24 hours prior to ICF; 3. Use of drugs or treatments including: (1) Use of similar drug or Previous inclusion in study of similar drugs within 4 weeks prior to dosing; (2) Use of potent immunomodifier (e.g., tacrolimus, triptonide). 4. History or suspicion of any disease listed as following: (1) History of systemic inflammatory disease except for gouty, Including but not limited to juvenile chronic arthritis, spondyloarthropathy, Crohn's disease, ulcerative colitis, psoriatic arthritis, and active vasculitis; (2) History of heart failure (New York Heart Association (NYHA) class III or IV), unstable angina, stroke, transient ischemic attack, myocardial infarction, or persistent arhythmia of clinical significant within the previous 6 months prior to dosing; (3) History of malignancy; (4) Received live or attenuated live vaccines within 3 months prior to first dosing of the trial, or planned to receive live or attenuated vaccines during the study period; (5) Diagnosed of herpes simplex with related symptoms; (6) History of tuberculosis (TB), or family contacts with patients with active TB who have not received appropriate and documented TB preventive treatment, or highly suspected of having TB based on chest X ray; (7) History of dyscrasia or any disease that can cause hemolysis or instability of red blood cells; (8) Diagnosed of active or recurrent digestive ulcer; (9) Blood donation or blood loss >= 400 ml within 3 months prior to dosing; (10) Inclusion of any clinical trial of drug or medical device (including placebo) within 4 weeks of the end of the study prior to administration, or within 5 half-lives of the study drug (the longer of 4 weeks and 5 half-lives will be used); (11) Diagnosed of infectious disease and received systemic antibiotic treatment within 2 weeks prior to administration; (12) Diagnosed of severe mental or neurological disease; (13) Secondary gout caused by various factors (accessed by physician); 5. Any of the laboratory test indicators meets the following criteria throughout screening period: (1) Hemoglobin 2 times ULN; (7) Total bilirubin > 2 times ULN; (8) Estimated glomerular filtration rate (eGFR) 450 ms in men and 470 ms in women at screening; 7. Persons who cannot be given intramuscular injections (e.g., patients who are on anticoagulant therapyorhave known hemorrhagic disorders such as idiopathic thrombocytopenic purpura); 8. Pregnant or lactating women; 9. Drug use or abuse that affects the evaluation of test results; 10. Any other factors that might influence the conduct of the study or the evaluation of the results accessed by investigator.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Change in Patient-assessed Pain Intensity in the Index Joint From Baseline at Time Points From 6 Hours to 7 Days for the First Gout Flare Treated in the Study as Measured by VAS;The Percent of Patients and the Median Time to Response;The Percent of Patients and the Median Time to Response;Value change in Physician-assessed Pain Intensity in the Index Joint from Baseline at Time Points From 6 Hours to 7 Days for the First Gout Flare Treated in the Study as Measured by 5-point Likert Scale;Physician's Assessment of Clinical Signs in Index Joint: pain when touched;Physician's Assessment of Clinical Signs in Index Joint: Swelling;Population pharmacokinetic characteristics of UA007;Immunogenic characteristics of UA007;Change From Baseline in the Inflammatory Biomarker of CRP, ESR and IL-1;Change From Baseline in the Inflammatory Biomarker of CRP, ESR and IL-1; | — |
Primary
| Measure | Time frame |
|---|---|
| Change in Patient-assessed Pain Intensity in the Index Joint From Baseline to 72 Hours for the First Gout Flare Treated in the Study as Measured by Visual Analogue Scale (VAS); | — |
Countries
China
Contacts
Public ContactLindi Jiang
Zhongshan Hospital Affiliated to Fudan University
Outcome results
None listed