drugset / Trial / NCT03593785

A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD8233 in Healthy Male Subjects With Increased Elevated LDL-C Levels.

NCT03593785 ↗

Phase 1 Completed 73 enrolled AstraZeneca Parexel · collab
RandomizedParallel-groupSingle-blindTreatment

Summary

AZD8233 has not been evaluated in clinical studies previously. This is a first-in-human (FiH) study. This study will assess the safety, tolerability and pharmacokinetics (PK) of AZD8233, following subcutaneous (SC) administration of single ascending dose (SAD) of AZD8233. This study will also investigate the pharmacodynamics (PD) of AZD8233 by investigating the effect of AZD8233 on levels of cholesterol and related biomarkers.

Timeline

Start
2018-08-03
Primary completion
2020-12-19
Completion
2020-12-19

Drugs

EvaluationDrugModalityDoseRoute
Subject AZD8233 Antisense oligonucleotide 40 mg/ml Subcutaneous

Indications