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

Launched by SHENYANG SUNSHINE PHARMACEUTICAL CO., LTD. · Oct 4, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called SSS11 for patients with gout and high uric acid levels (hyperuricemia). The main goal is to see how safe this treatment is and how well it is tolerated when given as multiple injections. The trial is designed for adults aged 65 and older who have a confirmed diagnosis of gout and have been tested to show high uric acid levels. Participants will go through a screening phase, receive treatment over a period of 4 to 8 weeks, and then have a follow-up observation period of 4 weeks.

To be eligible for this study, patients should not have had an acute gout attack recently and should not be taking any medications that lower uric acid levels. This includes drugs like allopurinol or febuxostat. Participants can expect to receive either the experimental treatment or a placebo (a non-active substance) in a way that ensures neither the patients nor the researchers know which one they are receiving during the treatment period. This helps ensure the results are reliable. Overall, this trial aims to explore if SSS11 can provide a new option for managing gout and hyperuricemia safely.

Gender

ALL

Eligibility 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)。