At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating AZD0780, Placebo, and 1 other intervention for Dyslipidemia. Completed, enrolled 183 participants across 3 sites in 2 countries.
Detailed 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.
Study Details
Timeline
Interventions
Subjects will receive AZD0780 orally as a single ascending dose.
Subjects will receive AZD0780 orally as a multiple ascending dose.
Subjects will receive AZD0780 orally as a single and multiple ascending dose.
Subjects will receive placebo matching the AZD0780 dose orally as a single ascending dose.
Subjects will receive placebo matching the AZD0780 dose orally as a multiple ascending dose.
Subjects will receive placebo matching the AZD0780 dose orally as a single and multiple ascending dose.
Subjects will receive rosuvastatin orally.