Evaluating the safety and effects of SSS11 in patients with gout and high uric acid levels
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
Run by Shenyang Sunshine Pharmaceutical Co., LTD. · NCT06629376 · Data updated 2026-11-12
This study is testing a new treatment called SSS11 to see if it can safely lower uric acid levels in people with gout.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Shenyang Sunshine Pharmaceutical Co., LTD. Industry-sponsored |
| Locations | 1 site (Shanghai) |
| Status | Recruiting |
| Started | November 20, 2023 |
| Main results expected | December 20, 2026 |
| Study ends | August 8, 2027 |
| Registry record updated | May 28, 2025 |
| Trial ID | NCT06629376 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients with a clinical diagnosis of gout in a non-acute phase and elevated blood uric acid levels.
✕Probably not a fit
Patients experiencing acute gout attacks or those who have recently used medications that lower uric acid levels may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial assesses the safety, tolerability, and pharmacokinetics of SSS11, a pegylated recombinant urate oxidase, in patients diagnosed with gout and hyperuricemia. The study involves a randomized, double-blind, placebo-controlled design with multiple doses administered over a treatment period of 4 to 8 weeks, followed by a 4-week observation phase. Participants will be monitored for their response to the treatment and any adverse effects that may arise during the trial.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for managing gout and hyperuricemia effectively.
How similar studies have gone: While this approach is novel, similar studies have explored urate oxidase treatments, indicating potential for success.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria:
* A patient with clinical diagnosis of gout (according to the 2015 ACR/EULAR gout classification criteria), non acute attack phase, and hyperuricemia {under normal purine diet, blood uric acid\>420 µ mol/L (7 mg/dl) not tested twice on an empty stomach on the same day}。
* Screening period blood uric acid\>420 µ mol/L (7mg/dl)。
Exclusion Criteria:
* Within 14 days prior to enrollment (or within 5 half lives of the drug, whichever is longer), medication that lowers uric acid levels or affects uric acid levels and related drugs (allopurinol, febuxostat, benzbromarone, probenecid, benzenesulfonazolone, Tongyifengning tablets, etc.) must be taken, or during the study period, other drugs that lower uric acid levels or affect uric acid levels and related drugs other than experimental drugs must not be discontinued。
* Patients with acute gout attacks within 14 days prior to enrollment。
* Previously received uric acid oxidase or treated with similar drugs such as pegolase or rabulidase。
* Individuals with a history of glucose-6-phosphate dehydrogenase (G6PD) deficiency or G6PD enzyme activity levels below the lower limit of normal。
* Individuals with a history of catalase deficiency or evidence that meets the diagnostic criteria for catalase deficiency。
* Malignant tumor patients (whether treated or not)。
Where it's running
-
HuaShan Hospital Fudan University project, ShangHai, China
Shanghai, China Recruiting
Study contacts
- Study coordinator: hejian zou, professor
- Email: mail@hjzou.com/zhangj_fudan@163.com
- Phone: 021-52889999
Similar studies
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.