BridgeMD
Tests treatment safety and results for Gout
Official title Safety, Tolerability, and Pharmacokinetic Characteristics of SSS11 in Patients With Gout and Hyperuricemia
ClinicalTrials.gov ID: NCT06629376
What this study is testing
What is Pegylated Recombinant Candida Utilis Uricase for Injection?
Pegylated Recombinant Candida Utilis Uricase for Injection is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for gout.
Also referred to as SSS11.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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。
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- A patient with clinical diagnosis of gout (according to the 2015 ACR/EULAR gout classification criteria), non acute attack phase, and hyperuricemia...
- Screening period blood uric acid\>420 µ mol/L (7mg/dl)。
You likely can't join if
- 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...
- 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)。
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.