Gout, Hyperuricemia
Conditions
Brief 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。
Interventions
DRUGPegylated 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
Sponsors
Shenyang Sunshine Pharmaceutical Co., LTD.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 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)。
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The primary outcome was safety. | up to 12 weeks | Assessment AEs by frequency and severity |
Secondary
| Measure | Time frame |
|---|---|
| Difference between post administration blood uric acid and baseline | up to 12 weeks |
| Duration of blood uric acid<360 μ mol/L | up to 12 weeks |
| Proportion of subjects with blood uric acid levels below 360 μ mol/L at each sample collection time point | up to 12 weeks |
Countries
China
Contacts
Primary Contacthejian zou, professor
Outcome results
None listed