The purpose of the study is to evaluate the safety, tolerability and pharmacokinetics (PK) of single ascending doses of AZD0292 administered via intravenous (IV) infusion in healthy Japanese participants.
This is a Phase I, randomized, double-blind, placebo-controlled, single ascending dose study in healthy Japanese participants to investigate 2 dose levels of AZD0292. Participants will be randomized to receive either AZD0292 or placebo, proceeding with sentinel cohorts. The study will comprise: * A Screening Period of maximum 28 days. * A Treatment Period during which participants will be resident at the site from the day before study intervention administration (Day -1) until at least 24 h post-EOI with study intervention; and discharged on Day 2. * A Follow-up Period from Day 3 to Day 16. * An extended Follow-up Period from Day 17 to Day 161.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
18
Research Site
Sumida-ku, Japan
Number of participants with adverse events (AEs), serious adverse events (SAEs) and adverse event of special interest (AESI)
To assess the safety and tolerability of AZD0292 following IV administration of single ascending doses to healthy Japanese adult participants.
Time frame: Up to Extended Follow-up Period (Day 161)
Maximum observed drug concentration (Cmax)
To characterize the Cmax of AZD0292 following administration of single ascending doses of AZD0292 to healthy Japanese adult participants.
Time frame: From Day 1 to Extended Follow-up Period (Day 161)
Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast)
To characterize the AUClast of AZD0292 following administration of single ascending doses of AZD0292 to healthy Japanese adult participants.
Time frame: From Day 1 to Extended Follow-up Period (Day 161)
Area under concentration-time curve from time 0 to infinity (AUCinf)
To characterize the AUCinf of AZD0292 following administration of single ascending doses of AZD0292 to healthy Japanese adult participants.
Time frame: From Day 1 to Extended Follow-up Period (Day 161)
Number of participants with positive anti-drug antibodies (ADAs) to AZD0292 in serum
To evaluate the ADA responses following administration of single ascending doses of AZD0292 to healthy Japanese adult participants.
Time frame: From Day 1 to Extended Follow-up Period (Day 161)
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