An Open-Label, Sequential, Ascending Single-Dose Safety, Tolerability, Pharmacokinetic and Pharmacodynamics Study of an Intravenous Infusion of SEL-037 in Subjects With Elevated Blood Uric Acid Levels
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 4
- 主要终点
- Safety and tolerability as assessed by frequency of drug related adverse events, graded by severity
研究概览
简要总结
This Study will evaluate the safety, pharmacokinetics, pharmacodynamics and immunogenicity of a single intravenous infusion of SEL-037 (pegsiticase), a pegylated uricase, in subjects with elevated blood uric acid levels. Uricase is an enzyme that converts uric acid to the readily soluble allantoin that is then excreted.
详细描述
This Study will evaluate the safety, pharmacokinetics, pharmacodynamics and immunogenicity of a single intravenous infusion of SEL-037 (pegsiticase), a pegylated uricase, in subjects with elevated blood uric acid levels. Uricase is an enzyme that converts uric acid to the readily soluble allantoin that is then excreted. Cohorts of Subjects will be given a single, ascending dose intravenous infusion of SEL-037 and then monitored for safety, uric acid levels and anti-drug-antibodies (ADAs) to SEL-037 for 30 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects ages 21 to 75 inclusive. Female subjects must be of non-childbearing potential;
- •Has at the Screening Visit a serum uric acid ≥ 6 mg/dL, with or without a history of gout;
- •The use of allopurinol, febuxostat (Uloric®), or probenecid as uric acid-lowering therapy is permissible if dosing has been stable for at least the month prior to the Screening Visit
- •Has adequate venous access and able to receive IV therapy;
- •Evidence of a personally signed and dated informed consent document indicating that subject has been informed of all pertinent aspects of the study;
排除标准
- •Prior exposure to any experimental or marketed uricase;
- •History of any allergy to pegylated products,
- •Glucose-6-phosphate dehydrogenase deficiency or known catalase deficiency;
- •History of hematological or autoimmune disorders, is immunosuppressed or immunocompromised;
- •Has participated in a clinical trial within 30 days of the Screening;
结局指标
主要结局
Safety and tolerability as assessed by frequency of drug related adverse events, graded by severity
时间窗: 30 days
To assess the safety and tolerability of a single infusion of SEL-037 as assessed by frequency of drug related adverse events, graded by severity
次要结局
- Immunogenicity of SEL-037 (measurement of anti-drug antibody levels)(30 days)
- Pharmacokinetics of SEL-037 (AUC)(30 days)
- Pharmacodynamics of SEL-037 (blood uric acid levels)(30 days)