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Safety, Tolerability, and Pharmacokinetic Characteristics of SSS11 in Patients With Gout and Hyperuricemia
Sponsor: Shenyang Sunshine Pharmaceutical Co., LTD.
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。
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2023-11-20
Completion Date
2027-08-08
Last Updated
2025-05-28
Healthy Volunteers
No
Conditions
Interventions
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