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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
144
Research Site
Los Alamitos, California, United States
NOT_YET_RECRUITINGResearch Site
South Miami, Florida, United States
RECRUITINGImmediate AEs within 1 hour of IMP administration
To assess the safety of AZD0543 administered as a single IM or IV dose compared to placebo
Time frame: Within 1 hour of IMP administration
Injection/infusion-related reactions
To assess the safety of AZD0543 administered as a single IM or IV dose compared to placebo
Time frame: Within 24 hours of IMP administration
Injection/infusion site reactions
To assess the safety of AZD0543 administered as a single IM or IV dose compared to placebo
Time frame: Through Day 8 post-IMP administration
AEs
To assess the safety of AZD0543 administered as a single IM or IV dose compared to placebo
Time frame: Through Day 91 post-IMP administration
SAEs, MAAEs, and AESIs
To assess the safety of AZD0543 administered as a single IM or IV dose compared to placebo
Time frame: Throughout the study post-IMP administration
AZD0543 serum concentrations over time
To assess the pharmacokinetics (PK) of AZD0543, in serum
Time frame: Study Day 1 baseline/post-dose; Study Day 2, 4, 8, 31, 91, 151, 271, 361
AZD0543 Cmax
To assess the pharmacokinetics (PK) of AZD0543, in serum
Time frame: Study Day 1 baseline/post-dose; Study Day 2, 4, 8, 31, 91, 151, 271, 361
AZD0543 Tmax
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To assess the pharmacokinetics (PK) of AZD0543, in serum
Time frame: Study Day 1 baseline/post-dose; Study Day 2, 4, 8, 31, 91, 151, 271, 361
AZD0543 t½λz
To assess the pharmacokinetics (PK) of AZD0543, in serum
Time frame: Study Day 1 baseline/post-dose; Study Day 2, 4, 8, 31, 91, 151, 271, 361
AZD0543 AUClast
To assess the pharmacokinetics (PK) of AZD0543, in serum
Time frame: Study Day 1 baseline/post-dose; Study Day 2, 4, 8, 31, 91, 151, 271, 361
AZD0543 AUCinf
To assess the pharmacokinetics (PK) of AZD0543, in serum
Time frame: Study Day 1 baseline/post-dose; Study Day 2, 4, 8, 31, 91, 151, 271, 361
AZD0543 CL
To assess the pharmacokinetics (PK) of AZD0543, in serum
Time frame: Study Day 1 baseline/post-dose; Study Day 2, 4, 8, 31, 91, 151, 271, 361
AZD0543 Vss
To assess the pharmacokinetics (PK) of AZD0543, in serum
Time frame: Study Day 1 baseline/post-dose; Study Day 2, 4, 8, 31, 91, 151, 271, 361
AZD0543 Vz
To assess the pharmacokinetics (PK) of AZD0543, in serum
Time frame: Study Day 1 baseline/post-dose; Study Day 2, 4, 8, 31, 91, 151, 271, 361
Incidence of ADA; magnitude of ADA response
To assess anti-drug antibody (ADA) responses to AZD0543 in serum
Time frame: Study Day 1 baseline; Study Day 8, 31, 91, 151, 361