The primary objective of this study is to evaluate the safety, tolerability and immunogenicity profile of single and multiple dose administrations of AMG 592 in healthy participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
64
Research Site
Aventura, Florida, United States
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Any clinically significant changes in physical examinations, clinical laboratory tests and vital signs will be recorded as TEAEs.
Time frame: Day 1 up to Day 57
Number of Participants with Anti-AMG 592 Antibodies
Time frame: Day 1 up to Day 57
Fold Change from Baseline in Absolute Cell Counts of Regulatory T Cells (Tregs)
Time frame: One week after AMG 592 administration (up to 7 days)
Fold Change from Baseline in Absolute Cell Counts of Conventional T Cells (Tcons)
Time frame: One week after AMG 592 administration (up to 7 days)
Fold Change from Baseline in Absolute Cell Counts of Natural Killer Cells (NKs)
Time frame: One week after AMG 592 administration (up to 7 days)
Maximum Observed Serum Concentration (Cmax) of AMG 592
Time frame: Day 1 up to Day 57
Time of Maximum Observed Concentration (tmax) of AMG 592
Time frame: Day 1 up to Day 57
Area Under the Concentration-time Curve (AUC) of AMG 592
Time frame: Day 1 up to Day 57
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