Evaluating the safety and effects of SSS11 in patients with gout and high uric acid levels
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
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 |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Shenyang Sunshine Pharmaceutical Co., LTD. Industry-sponsored |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT06629376 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are patients with a clinical diagnosis of gout in a non-acute phase and elevated blood uric acid levels.
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.
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 performed: While this approach is novel, similar studies have explored urate oxidase treatments, indicating potential for success.
Eligibility criteria
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 this trial is running
Shanghai
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.