Safety, Tolerability, and Pharmacokinetic Characteristics of SSS11 in Patients With Gout and Hyperuricemia
Condition(s) studied
Investigational drug(s) / intervention(s)
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
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
Other trials for the same condition
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.
View NCT06629376 on ClinicalTrials.gov ↗ ← All trials in China