This is a safety, tolerability, pharmacokinetics, and preliminary pharmacological study of multiple administration, dose escalation, randomized double-blind, placebo-controlled.The main purpose of this experiment is to evaluate the safety and tolerability of multiple injections of PEGylated recombinant Candida urate oxidase (test drug code: SSS11) in patients with gout and hyperuricemia.The experimental period includes a screening period of 4 weeks, a treatment period of 4 or 8 weeks, and an observation period of 4 weeks。
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
According to the dosage requirements of each experimental group, intravenous infusion should be administered for at least 2 hours each time
HuaShan Hospital Fudan University project, ShangHai, China
Shanghai, China
RECRUITINGThe primary outcome was safety.
Assessment AEs by frequency and severity
Time frame: up to 12 weeks
Difference between post administration blood uric acid and baseline
Time frame: up to 12 weeks
Duration of blood uric acid<360 μ mol/L
Time frame: up to 12 weeks
Proportion of subjects with blood uric acid levels below 360 μ mol/L at each sample collection time point
Time frame: up to 12 weeks
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