This is a Phase I, double-blind, placebo-controlled, randomised within each dose group, single ascending dose study, with the objective to assess the safety, tolerability and pharmacokinetic profile of AZD8529 in healthy Japanese subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
48
Research Site
London, United Kingdom
To asses the safety:Adverse events, vital signs, physical examinations, telemetry, dECGs, clinical chemistry and haematology labs including testosterone, prolactin, LH, FSH and TSH, and urinalysis.
Time frame: From screening period to follow-up, 42 days (maiximum).
To characterize the pharmacokinetics of AZD8529 in plasma and urine.
Time frame: Blood and urine sampling from pre-dose until 12 days post dose.
To collect and store DNA for future exploratory research
Time frame: One blood sampling after randomisation.
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