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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
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
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.
Age
18 - 50 years
Sex
MALE
Healthy Volunteers
Yes
Research Site
Glendale, California, United States
Start Date
January 16, 2020
Primary Completion Date
March 11, 2021
Completion Date
March 11, 2021
Last Updated
April 1, 2021
32
ACTUAL participants
AZD4831
DRUG
Placebo
DRUG
Lead Sponsor
AstraZeneca
Collaborators
NCT07219511
NCT07272902
Data Source & Attribution
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