Status:
COMPLETED
A Single and Multiple Ascending Dose Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD2389 in Healthy Participants
Lead Sponsor:
AstraZeneca
Conditions:
Healthy Participants
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 20 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 24 2025
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06138795
Start Date
November 20 2023
End Date
August 24 2025
Last Update
September 9 2025
Active Locations (1)
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1
Research Site
Glendale, California, United States, 91206