Actively Recruiting
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
Led by Shenyang Sunshine Pharmaceutical Co., LTD. · Updated on 2025-05-28
60
Participants Needed
1
Research Sites
33 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, pharmacokinetics, and preliminary pharmacological effects of multiple doses of PEGylated recombinant Candida urate oxidase (SSS11) in adults with gout and hyperuricemia. This phase 1 trial uses a randomized, double-blind, placebo-controlled design to gather important safety and dosing information. The study is sponsored by Shenyang Sunshine Pharmaceutical Co., LTD and aims to better understand how this investigational drug behaves in the body and its initial effects on uric acid levels. Participants will be assigned to one of several groups receiving different doses of SSS11 (4 mg, 8 mg, 12 mg, 16 mg, or 20 mg) or a placebo. The drug is given by intravenous infusion over at least 2 hours. The study includes a 4-week screening period, followed by a treatment period lasting either 4 or 8 weeks, and then a 4-week observation period. This setup allows researchers to compare various dose levels and monitor participants closely during and after treatment. Throughout the study, participants will undergo safety assessments for up to 12 weeks, including monitoring blood uric acid levels to evaluate changes from baseline. Researchers will measure the duration and proportion of time blood uric acid remains below 360 bc mol/L. The trial involves regular medical evaluations, laboratory tests, and close observation to track how well participants tolerate the injections and to collect detailed pharmacokinetic data on the investigational drug.
CONDITIONS
Brief 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 2015 ACR/EULAR criteria, not in acute attack phase
- Hyperuricemia with blood uric acid over 420 bc mol/L (7 mg/dl) confirmed twice on an empty stomach
- Blood uric acid above 420 bc mol/L during screening period
You will not qualify if you...
- Use of uric acid lowering or affecting drugs within 14 days prior to enrollment or during study except experimental drug
- Acute gout attacks within 14 days prior to enrollment
- Prior treatment with uric acid oxidase or similar drugs like pegolase or rabulidase
- History of glucose-6-phosphate dehydrogenase (G6PD) deficiency or low G6PD enzyme activity
- History or evidence of catalase deficiency
- Any malignant tumor, treated or untreated
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 weeks
Participants receive intravenous infusions of the study drug or placebo according to their assigned dose group.
Repeated infusions with visits for dosing and safety monitoring over up to 12 weeks
Trial Site Locations
Total: 1 location
1
HuaShan Hospital Fudan University project, ShangHai, China
Shanghai, China
Actively Recruiting
Research Team
H
hejian zou, professor
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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