A Single and Multiple Ascending Dose Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD2389 in Healthy Participants

Launched by ASTRAZENECA · Nov 14, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating a new medication called AZD2389 to understand how safe it is and how the body processes it. The study involves healthy participants who will receive either a single dose or multiple doses of the medication. Researchers want to learn how well the drug works and how it affects the body. This study is currently looking for participants aged between 65 and 88, regardless of gender.

To be eligible for this trial, participants must be healthy individuals with no serious medical issues and suitable veins for blood draws. There are specific groups being targeted, including those of Japanese and Chinese descent, who must have a certain ancestry background. Participants can expect to receive careful monitoring throughout the study, and they will need to follow specific guidelines to ensure their safety. It’s important to note that individuals with certain health conditions, recent surgeries, or a history of substance abuse may not qualify for this study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Healthy male and female (of non-childbearing potential) participants with suitable veins for cannulation or repeated venipuncture.
• • For the healthy Japanese cohorts (Parts A2 and B2): healthy participants are to be Japanese (e.g., natives of Japan or Japanese Americans), defined as having both parents and 4 grandparents who are Japanese. This includes healthy second and third generation participants of Japanese descent whose parents or grandparents are living in a country other than Japan.
• • For the healthy Chinese cohort (Part A3): healthy participants are to be Chinese defined as having both parents and 4 grandparents who are ethnically Chinese. This includes second and third generation Chinese whose parents or grandparents are living in a country other than China.
• Exclusion Criteria:
• • Any clinically important illness, medical/surgical procedure or trauma within 4 weeks of the first administration of IMP.
• • Known or suspected history of alcohol or drug abuse and smokers.
• • Plasma donation within one month of the Screening Visit or any blood donation/blood loss \> 500 mL during the 3 months prior to the Screening Visit.
• • History of coagulation or bleeding disorders or use of anti-platelets/anti-coagulants during the 3 months prior to the Screening Visit, as judged by the investigator.
• • History of hypersensitivity as judged by the investigator, to drugs with a similar chemical structure or class.
• • History of severe dermatological disorders, eg, bullous pemphigoid or Stevens-Johnson syndrome, or clinically significant new or healing wounds in areas of the body not always covered by clothing such as face, forearm, and lower leg, as judged by the investigator.