A Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics With AZD0780 Following Repeated Dose Administration in Healthy Adults With Elevated LDL-C Levels

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

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.

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.

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.