jRCT2051240068已完成不适用
A Trial to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety and Tolerability of Zerlasiran in Japanese Subjects With Elevated Serum Lipoprotein(a)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 主要终点
- PK parameters of zerlasiran
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Other
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 20age old over 至 70age old under（—）
- 性别
- All
入选标准
- •Males or nonpregnant, nonlactating females who are 20 to 70 years of age.
- •Body mass index at least 18 kg/m2 but no more than 32 kg/m2
- •Elevated Lp(a) in the blood
- •Agrees to use effective contraception, if applicable
排除标准
- •Patients have a history of established cardiovascular disease.
- •Patients with a history of cancer
- •Patients with moderate or serious liver conditions
- •Patients with serious mental illness or psychiatric disorder
- •Positive for hepatitis B, hepatitis C and/or human immunodeficiency virus (HIV)
- •History or clinical evidence of alcohol misuse and/or illegal drug use within the 6 months before Screening
- •History of multiple drug allergies
- •History of intolerance to subcutaneous injections (hypersensitivity etc.) or scarring in skin areas where subcutaneous doses may need to be administered.
- •Type 1 diabetes mellitus or poorly controlled (glycated haemoglobin 10% and over or 86 mmol/mol and over) type 2 diabetes mellitus
结局指标
主要结局
PK parameters of zerlasiran
The pharmacokinetic (PK) parameters of zerlasiran following single subcutaneous administration of up to 4 different doses
次要结局
未报告次要终点
研究者
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