Actively Recruiting
Safety, Tolerability, and Pharmacokinetic Characteristics of SSS11 in Patients With Gout and Hyperuricemia
Led by Shenyang Sunshine Pharmaceutical Co., LTD. · Updated on 2025-05-28
60
Participants Needed
1
Research Sites
193 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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。
CONDITIONS
Official Title
Safety, Tolerability, and Pharmacokinetic Characteristics of SSS11 in Patients With Gout and Hyperuricemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 65 years
- Clinical diagnosis of gout according to the 2015 ACR/EULAR gout classification criteria, in non-acute attack phase
- Hyperuricemia with blood uric acid > 420 BClmol/L (7 mg/dl) confirmed by at least two fasting tests on the same day
- Blood uric acid > 420 BClmol/L (7 mg/dl) during screening period
You will not qualify if you...
- Use of medications that lower or affect uric acid levels within 14 days before enrollment or during the study, except the experimental drug
- Acute gout attacks within 14 days prior to enrollment
- Prior treatment with uric acid oxidase or similar drugs such as pegolase or rabulidase
- History of glucose-6-phosphate dehydrogenase (G6PD) deficiency or G6PD enzyme activity below normal
- History or diagnostic evidence of catalase deficiency
- Current or past malignant tumors, regardless of treatment status
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
HuaShan Hospital Fudan University project, ShangHai, China
Shanghai, China
Actively Recruiting
Research Team
H
hejian zou, professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
6
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