AMG 529 20160338 First in Human Study


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Primary Outcome Measures:

  • Incidence of treatment-emergent adverse events ; safety assessments [ Time Frame: Cohorts 1, 2 and 6 (up to 30 days); Cohort 3, 4 and 5 (up to 57 days) ]

    Number of participants with treatment-emergent adverse events

  • Safety laboratory analytes [ Time Frame: Cohorts 1, 2 and 6 (up to 30 days); Cohort 3, 4 and 5 (up to 57 days) ]

    Clinically significant changes in safety laboratory analytes

  • Vital signs [ Time Frame: Cohorts 1, 2 and 6 (up to 30 days); Cohort 3, 4 and 5 (up to 57 days) ]

    Clinically significant changes in vital sigs

  • Electrocardiograms (ECGs) [ Time Frame: Cohorts 1, 2 and 6 (up to 30 days); Cohort 3, 4 and 5 (up to 57 days) ]

    Clinically significant changes in ECGs

Secondary Outcome Measures:

  • PK parameter of maximum observed concentration [ Time Frame: Cohorts 1, 2 and 6 (up to 30 days); Cohort 3, 4 and 5 (up to 57 days) ]

    PK effect

  • PK parameter of time of of maximum observed concentration (tmax) [ Time Frame: Cohorts 1, 2 and 6 (up to 30 days); Cohort 3, 4 and 5 (up to 57 days) ]

    PK effect

  • PK parameter of area under the concentration time curve (AUC) [ Time Frame: Cohorts 1, 2 and 6 (up to 30 days); Cohort 3, 4 and 5 (up to 57 days) ]

    PK effect

  • ALP levels [ Time Frame: Cohorts 1, 2 and 6 (up to 30 days); Cohort 3, 4 and 5 (up to 57 days) ]

    PD Parameter

  • Total cholesterol [ Time Frame: Cohorts 1, 2 and 6 (up to 30 days); Cohort 3, 4 and 5 (up to 57 days) ]

    PD Paramater: Lipid levels

  • LDL-C [ Time Frame: Cohorts 1, 2 and 6 (up to 30 days); Cohort 3, 4 and 5 (up to 57 days) ]

    PD Parameter: Lipid levels

  • HDL-C [ Time Frame: Cohorts 1, 2 and 6 (up to 30 days); Cohort 3, 4 and 5 (up to 57 days) ]

    PD Parameter: Lipid levels

  • Triglycerides [ Time Frame: Cohorts 1, 2 and 6 (up to 30 days); Cohort 3, 4 and 5 (up to 57 days) ]

    PD Parameter: Lipid levels

This is a randomized, double-blind, placebo-controlled, ascending single-dose study in healthy subjects, which will be conducted at 1 to 3 sites in the United States.

Approximately 48 subjects will enroll in 1 of 6 dose cohorts (8 per cohort).