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

Официальное название

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

Обзор

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。

Вмешательства

• Препарат Pegylated Recombinant Candida Utilis Uricase for Injection
  According to the dosage requirements of each experimental group, intravenous infusion should be administered for at least 2 hours each time

Первичные конечные точки

• The primary outcome was safety. [Срок оценки: up to 12 weeks]

Вторичные конечные точки (3)

• Difference between post administration blood uric acid and baseline [Срок оценки: up to 12 weeks]
• Duration of blood uric acid<360 μ mol/L [Срок оценки: up to 12 weeks]
• Proportion of subjects with blood uric acid levels below 360 μ mol/L at each sample collection time point [Срок оценки: up to 12 weeks]

Критерии участия

Критерии включения

• 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)。

Критерии исключения

• 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)。

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• HuaShan Hospital Fudan University project, ShangHai, China — Шанхай

Идентификаторы

NCT: NCT06629376 · SYSS-SSS11-UND-I-03

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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