A Phase I, Randomized, Single-blind, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD2389 After Single and Multiple Ascending Doses to Healthy Participants.

AstraZeneca1 site in 1 country120 target enrollmentNovember 20, 2023

ConditionsHealthy Participants

InterventionsAZD2389 Placebo

Overview

Phase: Phase 1
Intervention: AZD2389
Conditions: Healthy Participants
Sponsor: AstraZeneca
Enrollment: 120
Locations: 1
Primary Endpoint: Part A (SAD): Number of participants with adverse events (AE) and serious adverse events (SAE)
Status: Completed
Last Updated: 7 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Detailed Description

This is a Phase I, First In Human (FIH), randomized, single-blind, placebo-controlled, single and multiple ascending dose study in healthy male and/or female participants of non-childbearing potential including healthy participants of Chinese and Japanese ethnicity performed at a single center. The study consists of 2 parts: Part A and Part B. Part A has been planned to be conducted with 78 participants and Part B has been planned to be conducted with 32 participants. Each participant in Part A and Part B will be involved in the study for up to 8 weeks.

Registry

clinicaltrials.gov

Start Date

November 20, 2023

End Date

August 24, 2025

Last Updated

7 months ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

AstraZeneca

Responsible Party

Sponsor

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.

Arms & Interventions