This is an open-label study to assess safety, tolerability, and pharmacokinetics of Aldafermin (NGM282) in healthy adult male Japanese and non-Japanese subjects
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
36
Single dose of aldafermin
NGM Clinical Study Site 112
Cypress, California, United States
Maximum observed plasma concentration (Cmax) of a single dose aldafermin
Maximum observed plasma concentration (Cmax) of aldafermin (Day 1 through Day 4)
Time frame: 4 days
Area under the concentration-time curve of a single dose aldafermin
Area under the concentration-time curve from time zero extrapolated to infinity (AUC infinity)
Time frame: 4 days
Time to maximum concentration (Tmax) of a single dose aldafermin
Time to maximum concentration (Tmax)
Time frame: 4 days
Apparent terminal elimination half-life (T1/2) of a single dose aldafermin
Apparent terminal elimination half-life (T1/2)
Time frame: 4 days
Frequency of adverse events
Frequency of treatment-emergency adverse events (TEAE) and serious adverse events (SAEs)
Time frame: 10 days
Type of adverse events
Severity and duration of treatment-emergency adverse events (TEAE) and serious adverse events (SAEs)
Time frame: 10 days
Absolute change in concentration of biomarker 7-alpha-hydroxy-4-cholesten-3-one (C4)
Absolute change from baseline
Time frame: 6 and 24 hours post dose
Percent change of C4
Percent change from baseline
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Time frame: 6 and 24 hours post dose