A Single and Multiple Ascending Dose Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD2389 in Healthy Participants
- Conditions
- Healthy Participants
- Registration Number
- NCT06138795
- Lead Sponsor
- AstraZeneca
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> - Healthy male and female (of non-childbearing potential) participants with suitable<br> veins for cannulation or repeated venipuncture.<br><br> - For the healthy Japanese cohorts (Parts A2 and B2): healthy participants are to be<br> Japanese (e.g., natives of Japan or Japanese Americans), defined as having both<br> parents and 4 grandparents who are Japanese. This includes healthy second and third<br> generation participants of Japanese descent whose parents or grandparents are living<br> in a country other than Japan.<br><br> - For the healthy Chinese cohort (Part A3): healthy participants are to be Chinese<br> defined as having both parents and 4 grandparents who are ethnically Chinese. This<br> includes second and third generation Chinese whose parents or grandparents are<br> living in a country other than China.<br><br>Exclusion Criteria:<br><br> - Any clinically important illness, medical/surgical procedure or trauma within 4<br> weeks of the first administration of IMP.<br><br> - Known or suspected history of alcohol or drug abuse and smokers.<br><br> - Plasma donation within one month of the Screening Visit or any blood donation/blood<br> loss > 500 mL during the 3 months prior to the Screening Visit.<br><br> - History of coagulation or bleeding disorders or use of<br> anti-platelets/anti-coagulants during the 3 months prior to the Screening Visit, as<br> judged by the investigator.<br><br> - History of hypersensitivity as judged by the investigator, to drugs with a similar<br> chemical structure or class.<br><br> - History of severe dermatological disorders, eg, bullous pemphigoid or<br> Stevens-Johnson syndrome, or clinically significant new or healing wounds in areas<br> of the body not always covered by clothing such as face, forearm, and lower leg, as<br> judged by the investigator.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Part A (SAD): Number of participants with adverse events (AE) and serious adverse events (SAE);Part B (MAD): Number of participants with AE and SAE
- Secondary Outcome Measures
Name Time Method