A Randomized, Open-label, Single-center, Parallel Study in Subjects With Normal or Elevated Low-density Lipoprotein Cholesterol Level to Compare the Pharmacokinetics and Pharmacodynamics of the Two Formulations of QLC7401 Injection
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- CL/F
研究概览
简要总结
The purpose of this study is to compare the pharmacokinetics and pharmacodynamics behavior of the two formulation of QLC7401 injection to further evaluate the effect of the production site change.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- 是
入选标准
- •Males and females who are 18 to 65 years of age.
- •BMI is within the range of 18~28 kg/m2 (including the boundary value).
- •LDL-C is within the range of 1.8 mmol/L (70 mg/dl) and 4.1 mmol/L (158 mg/dl) (including the lower boundary value). TG is less than or equal to 4.5 mmol/L (400 mg/dl).
- •TC is less than 6.2 mmol/L (239 mg/dl).
排除标准
- •Subjects with confirmed diabetes.
- •Subjects with severe active psychiatric illness or disorder.
- •eGFR is less than 90 ml/min.
- •AST is equal to or above the 2 fold of upper limit of normal value or TBIL is equal to or above the 1.5 fold of upper limit of normal value.
- •Subjects administered prescription drugs 14 days before the first drug administration.
研究组 & 干预措施
QLC7401 injection
干预措施: QLC7401 injection (Drug)
RBD7022 injection
干预措施: RBD7022 injection (Drug)
结局指标
主要结局
CL/F
时间窗: 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hours post dose
Apparent total clearance of the drug from plasma after oral administration of QLC7401 and active metabolites.
Cmax
时间窗: 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hours post dose
Maximum plasma concentration of QLC7401 and active metabolites.
VZ/F
时间窗: 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hours post dose
Apparent volume of distribution after oral administration of QLC7401 and active metabolites.
AUC
时间窗: 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hours post dose
Area under the concentration-time curve of QLC7401 and active metabolites.
t1/2
时间窗: 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hours post dose
Terminal elimination half-life of QLC7401 and active metabolites.
Tmax
时间窗: 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 48 hours post dose
Time of maximum observed concentration of QLC7401 and active metabolites..
次要结局
未报告次要终点