Clinical Trial

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

Recruiting Phase 1
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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。
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-10-04.
Trial Details
NCT Number NCT06629376
Lead Sponsor Shenyang Sunshine Pharmaceutical Co., LTD.
Conditions Gout, Hyperuricemia
Enrollment 60 participants
Start Date 2023-11-20
Primary Completion 2026-12-20 (estimated)
Study Completion 2027-08-08 (estimated)
Updated on ClinicalTrials.gov 2025-05-28