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Taking peoplePhase 1

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

Key facts

Phase
Phase 1

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 65 years old?

Source: NCT06629376, who can take part

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

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Trial details

Who runs it
Shenyang Sunshine Pharmaceutical Co., LTD.
Trial code
NCT06629376
Record updated
28 May 2025
Original description
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。Read full original descriptionShow less

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 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。

Inclusion: 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: 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 catalase deficiency or evidence that meets the diagnostic criteria for catalase deficiency。; Malignant tumor patients (whether treated or not)。; Individuals with a history of glucose-6-phosphate dehydrogenase (G6PD) deficiency or G6PD enzyme activity levels below the lower limit of normal。.

ClinicalTrials.gov NCT06629376