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COMPLETED
NCT05384262
PHASE1

A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD0780 in Healthy Subjects

Sponsor: AstraZeneca

View on ClinicalTrials.gov

Summary

This study will assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of AZD0780 following single and multiple dose administration to healthy subjects with or without elevated Low-Density Lipoprotein-Cholesterol (LDL-C) levels. This study will consist of two parts (Parts A and B). 56 subjects have been planned for Part A and 141 subjects for Part B. Additional subjects may be included for the optional cohorts depending upon emerging data.

Official title: A Phase I, Randomized, Single-Blind, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD0780 Following Single and Multiple Ascending Dose Administration to Healthy Subjects With or Without Elevated LDL-C Levels

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

183

Start Date

2022-05-18

Completion Date

2024-06-14

Last Updated

2026-09-09

Healthy Volunteers

Yes

Conditions

Interventions

DRUG

AZD0780

Subjects will receive AZD0780 orally as a single ascending dose.

DRUG

AZD0780

Subjects will receive AZD0780 orally as a multiple ascending dose.

DRUG

AZD0780

Subjects will receive AZD0780 orally as a single and multiple ascending dose.

DRUG

Placebo

Subjects will receive placebo matching the AZD0780 dose orally as a single ascending dose.

DRUG

Placebo

Subjects will receive placebo matching the AZD0780 dose orally as a multiple ascending dose.

DRUG

Placebo

Subjects will receive placebo matching the AZD0780 dose orally as a single and multiple ascending dose.

DRUG

Rosuvastatin

Subjects will receive rosuvastatin orally.

Locations (3)

Research Site

Glendale, California, United States

Research Site

Brooklyn, Maryland, United States

Research Site

Harrow, United Kingdom