Study of Safety and PK of AZD0543 in Healthy Adults
Start Date
8/31/2026
Completion Date
12/20/2027
Summary
The purpose of this study is to assess the safety and PK of AZD0543 compared to placebo in healthy adults 18 to 55 years of age. AZD0543 or placebo will be administered as single IM or IV dose. The study duration will be approximately 12 months for each participant following administration of IMP.
Detailed Description
A phase 1, randomized, double-blind, placebo-controlled, dose-escalation study to evaluate the safety, tolerability and pharmacokinetics of AZD0543 in healthy adults 18-55 years of age. 144 participants will be randomized to receive either one of 3 dose levels of AZD0543 or a placebo comparator of the same volume. AZD0543 or placebo will be administered as a single dose on Day 1 via intramuscular (IM) injection or intravenous (IV) infusion. Participants will be followed for approximately 1 year.
Eligibility Criteria
Age Range: 18 years to 55 years
Interventions
AZD0543
Placebo
Conditions
Locations
Research Site
Los Alamitos, California 90720
United States
Research Site
South Miami, Florida 33143
United States