NCT07423598已完成1 期
A Phase I Randomized Single-blind Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD0780 Following Repeated Dose Administration to Healthy Adults With Elevated LDL-C Levels
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Relative change from baseline in LDL-C levels
研究概览
简要总结
The purpose of this study is to evaluate pharmacodynamics (PD) of AZD0780 compared with placebo by assessment of low-density lipoprotein-cholesterol (LDL-C) levels following repeated oral dosing in healthy adults with elevated LDL-C levels.
详细描述
This is a Phase I, randomized, single-blind, placebo-controlled study of AZD0780 in healthy adults with elevated LDL-C levels.
The study comprises of:
- An optional Pre-screening visit.
- A Screening Period (maximum 28 days).
- Admission to the Clinical Unit (Day -1).
- A Treatment Period for administration of AZD0780 or placebo (Days 1 to 28).
- Follow-up Visit 12 ± 2 days after the last study intervention dose.
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
- Double (Participant, Investigator)
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
- •Healthy participants with suitable veins for cannulation or repeated venipuncture.
- •All females must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit.
- •Females of childbearing potential must not be lactating and if heterosexually active must agree to use an approved method of highly effective contraception.
- •Females of non-childbearing potential must be confirmed as postmenopausal or have documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy but not tubal ligation or tubal occlusion.
- •Have a body mass index between 18 and 35 kg/m2 inclusive and weigh at least 50 kg.
- •Fasting LDL-C ≥ 70 mg/dL and < 190 mg/dL at Screening.
排除标准
- •History of any clinically important disease or disorder.
- •History or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
- •Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the first administration.
- •Any abnormal vital signs or laboratory values including clinical chemistry, hematology, coagulation, or urinalysis results.
- •Current smokers or those who have smoked or used nicotine products (including e-cigarettes) or any known or suspected history of alcohol or drug abuse.
- •History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity, especially to drugs with a similar chemical structure or class to AZD0780.
研究组 & 干预措施
Placebo
Placebo Comparator
Participants will receive a dose of matching placebo to AZD0780
干预措施: Placebo (Drug)
AZD0780
Experimental
Participants will receive a dose of AZD0780.
干预措施: AZD0780 (Drug)
结局指标
主要结局
Relative change from baseline in LDL-C levels
时间窗: From Baseline (Day 1) to 4 weeks
To determine the pharmacodynamic profile of AZD0780 versus placebo by evaluating LDL-C concentrations after repeated oral administration
次要结局
- Area under concentration-time curve from time 0 to infinity (AUCinf)(At pre-defined intervals from Day 1 to Day 40)
- Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast)(At pre-defined intervals from Day 1 to Day 40)
- Maximum observed drug concentration (Cmax)(At pre-defined intervals from Day 1 to Day 40)
- Number of participants with adverse events (AEs) and serious adverse events (SAEs)(Upto Day 40)
研究者
研究点 (1)
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