To evaluate the safety and tolerability of peguricase for injection with methotrexate in patients with gout who remain uncontrolled after standardized treatment with conventional uric acid-lowering drugs, to determine the recommended dose for phase II clinical trials, and to provide basis for formulation of administration regimen for phase II clinical trials.
Willing and able to give informed consent.
Male and female aged between 18 and 70 years old , regardless of gender.
Male weight ≥50 kg, female weight ≥45 kg, body mass index (BMI) in the range of (19-30) kg/m2 (including 19 and 30)；
The clinical diagnosis of gout met the criteria of American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) in 2015，patients were in non-acute attack at screening or at least 2 weeks after complete remission of acute attack, and sUA ≥420 μmol/L at screening；
Patients had active systemic infection within 2 weeks before enrollment，including an infection for which treatment was being received；
Having a chronic or recurrent infection, such as recurrent pneumonia or chronic bronchitis; Patients with active or severe lung disease or pulmonary insufficiency on chest imaging, or current pulmonary fibrosis or bronchiectasis；
Patients who are on anti-TB treatment or have active TB；
Diagnosis of osteomyelitis；
Sequential
SIBP-R002
DrugInjection; strength: 4mg. Each group consists of 12 participants. Firstly, 4 sentinel participants were enrolled in the single dose phase of peruricase for injection and methotrexate. After the sentinel participants completed a 5-day safety observation of the single dose, the remaining 8 participants in this group can be enrolled simultaneously. If there are no special circumstances, the participants in this group will enter the multi-dose stage of peruricase for injection combined with methotrexate within 2-4 weeks after completing a single dose.
SIBP-R002
DrugInjection; strength: 8mg. Each group consists of 12 participants. Firstly, 4 sentinel participants were enrolled in the single dose phase of peruricase for injection and methotrexate. After the sentinel participants completed a 5-day safety observation of the single dose, the remaining 8 participants in this group can be enrolled simultaneously. If there are no special circumstances, the participants in this group will enter the multi-dose stage of peruricase for injection combined with methotrexate within 2-4 weeks after completing a single dose.
SIBP-R002
DrugInjection; strength: 12mg. Each group consists of 12 participants. Firstly, 4 sentinel participants were enrolled in the single dose phase of peruricase for injection and methotrexate. After the sentinel participants completed a 5-day safety observation of the single dose, the remaining 8 participants in this group can be enrolled simultaneously. If there are no special circumstances, the participants in this group will enter the multi-dose stage of peruricase for injection combined with methotrexate within 2-4 weeks after completing a single dose.
Methotrexate
DrugCombination drugs: Methotrexate, dose15 mg, oral.
AE(Adverse Events)
That is adverse events, any adverse events that occurred to the participant during the study period.
SAE(Serious Adverse Events)
That is serious adverse events, any serious adverse events that occurred to the participant during the study period.
AUC(Area Under The Plasma Concentration Versus Time Curve)
It shows the degree to which a drug is absorbed and used in the body
Cmax(Peak Plasma Concentration)
It shows the highest plasma concentration of a drug that can be achieved after administration.
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Shanghai Institute Of Biological Products
Lead sponsor
The First Affiliated Hospital of Bengbu Medical University
Collaborator
The First Affiliated Hospital of Henan University of Science and Technology
Collaborator
