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A Study to Assess the Effect AZD4831 in Japanese and Chinese Healthy Volunteers

Heart Failure With Preserved Ejection Fraction (HFpEF) Clinical Trial

Official title:
A Phase I, Randomized, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD4831 Following Multiple-ascending Dose Administration in Japanese and Chinese Healthy Volunteers

Clinical Trial Summary

This study is randomized, single-blind, placebo-controlled Phase 1 study aimed to assess the safety and efficacy, pharmacokinetics and pharmacodynamics of multiple doses of oral AZD4831 in healthy Japanese and Chinese volunteers

Clinical Trial Description

This is a Phase I, randomized, single-blind, placebo-controlled, multiple-ascending dose (MAD), sequential-group study in healthy Japanese (Part 1, Cohorts 1, 2, and 3) and Chinese (Part 2, Cohort 4) male subjects, conducted at a single study center. Four cohorts are planned, but one additional cohort may be enrolled based on a Safety Review Committee (SRC) decision. The 4 multiple dose levels are planned as follows: - Cohort 1: Dose 1 - Cohort 2: Dose 2 - Cohort 3: Dose 3 - Cohort 4: Dose 2 A randomization ratio of 3:1 (AZD4831 versus placebo) will be used. For each cohort the study will comprise: - Screening Period of a maximum of 28 days. - A Treatment Period during which subjects are resident in the study center from the day before first dosing with the Investigational Medicinal Product (Day -1) until at least 48 hours after last dosing on Day 10; subjects will be discharged on Day 12. - Three Follow-up Visits on Day 14, Day 16 (±1 day), and Day 20 (±1 day). - A Final Follow-up Visit on Day 24 (±2 days). Each subject will be involved in the study for 8 to 9 weeks. ;

Study Design

Related Conditions & MeSH terms

  • Heart Failure
  • Heart Failure With Preserved Ejection Fraction (HFpEF)
Clinical Trial Details
NCT number NCT04232345
Study type Interventional
Source AstraZeneca
Contact
Status Completed
Phase Phase 1
Start date January 16, 2020
Completion date March 11, 2021
View Details
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