RECRUITINGPhase 1INTERVENTIONAL

Safety, Tolerability, and Pharmacokinetic Characteristics of SSS11 in Patients With Gout and Hyperuricemia

Safety, Tolerability, Pharmacokinetics, and Preliminary Pharmacological Studies of SSS11 in Patients With Gout and Hyperuricemia After Multiple Administrations, Dose Escalation, Randomized Double-blind, Placebo-controlled Trials

About This Trial

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。

Who May Be Eligible (Plain English)

Who May Qualify: - 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)。 Who Should NOT Join This Trial: - 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)。 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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)。

Treatments Being Tested

DRUG

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

Locations (1)

HuaShan Hospital Fudan University project, ShangHai, China

Shanghai, China