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
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The primary outcome was safety.
研究概览
简要总结
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。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)。
排除标准
- •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)。
研究组 & 干预措施
Experimental： group3
injection；strength；12mg
干预措施: Pegylated Recombinant Candida Utilis Uricase for Injection (Drug)
Experimental： group4
injection；strength；16mg
干预措施: Pegylated Recombinant Candida Utilis Uricase for Injection (Drug)
Experimental： group2
injection；strength；8mg
干预措施: Pegylated Recombinant Candida Utilis Uricase for Injection (Drug)
Experimental： group1
injection；strength；4mg
干预措施: Pegylated Recombinant Candida Utilis Uricase for Injection (Drug)
Experimental： group5
injection；strength；20mg
干预措施: Pegylated Recombinant Candida Utilis Uricase for Injection (Drug)
Placebo control group
The same volume of placebo as SSS11
干预措施: Pegylated Recombinant Candida Utilis Uricase for Injection (Drug)
结局指标
主要结局
The primary outcome was safety.
时间窗: up to 12 weeks
Assessment AEs by frequency and severity
次要结局
- Difference between post administration blood uric acid and baseline(up to 12 weeks)
- Duration of blood uric acid<360 μ mol/L(up to 12 weeks)
- Proportion of subjects with blood uric acid levels below 360 μ mol/L at each sample collection time point(up to 12 weeks)