NCT04232345

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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

Detailed 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.

Conditions

• Heart Failure With Preserved Ejection Fraction (HFpEF)

Interventions

Type	Name	Description
DRUG	AZD4831	Subjects will be fasted for at least 10 hours before receiving the AZD4831 in the form of an oral suspension.
DRUG	Placebo	Subjects will be fasted for at least 10 hours before receiving the placebo in the form of an oral suspension.

Timeline

• Start date: 2020-01-16
• Primary completion: 2021-03-11
• Completion: 2021-03-11
• First posted: 2020-01-18
• Last updated: 2021-04-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study