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

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy Participants

In brief

This study will assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of AZD2389 following single and multiple dose administration (SAD/MAD) to healthy participants.

Key facts

Study ID

NCT06138795

Run by

AstraZeneca

People needed

120

Starts

2023-11-20

Expected to finish

2025-08-24

Last updated by the study team

2025-09-09

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Research Site — Glendale, California, United States

Full record on ClinicalTrials.gov

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