Pegylated Recombinant Candida Utilis Uricase for Injection
Pegylated Recombinant Candida Utilis Uricase for Injection: According to the dosage requirements of each experimental group, intravenous infusion should be administered for at least 2 hours each time
Study summary
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。
Eligibility
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria:
* A patient with clinical diagnosis of gout (according to the 2015 ACR/EULAR gout classification criteria), non acute attack phase, and hyperuricemia {under normal purine diet, blood uric acid\>420 µ mol/L (7 mg/dl) not tested twice on an empty stomach on the same day}。
* Screening period blood uric acid\>420 µ mol/L (7mg/dl)。
Exclusion Criteria:
* Within 14 days prior to enrollment (or within 5 half lives of the drug, whichever is longer), medication that lowers uric acid levels or affects uric acid levels and related drugs (allopurinol, febuxostat, benzbromarone, probenecid, benzenesulfonazolone, Tongyifengning tablets, etc.) must be taken, or during the study period, other drugs that lower uric acid levels or affect uric acid levels and related drugs other than experimental drugs must not be discontinued。
* Patients with acute gout attacks within 14 days prior to enrollment。
* Previously received uric acid oxidase or treated with similar drugs such as pegolase or rabulidase。
* Individuals with a history of glucose-6-phosphate dehydrogenase (G6PD) deficiency or G6PD enzyme activity levels below the lower limit of normal。
* Individuals with a history of catalase deficiency or evidence that meets the diagnostic criteria for catalase deficiency。
* Malignant tumor patients (whether treated or not)。
Primary outcome measure(s)
The primary outcome was safety. — up to 12 weeks Assessment AEs by frequency and severity
Trial sites (1)
Facility
City
Region
Status
HuaShan Hospital Fudan University project, ShangHai, China
Shanghai
China
Recruiting
More Shenyang Sunshine Pharmaceutical Co., LTD. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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