This is a single center, randomized, double-blind, placebo-controlled study to assess the pharmacokinetics, safety, and tolerability of subcutaneous administration of TEV-48125 (single ascending doses and single doses up to 900 mg) in Japanese and Caucasian healthy subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
64
Subcutaneous administration Dose Regimen 1
Subcutaneous administration Dose Regimen 2
Subcutaneous administration Dose Regimen 3
Teva Investigational Site 13529
Glendale, California, United States
Maximum observed plasma drug concentration (Cmax)
Time frame: 33 weeks
Time to maximum observed plasma drug concentration (tmax)
Time frame: 33 weeks
AUC from time 0 to the time of the last measurable plasma drug concentration (AUC0-t)
Time frame: 33 weeks
AUC from time 0 to 672 hours (4 weeks) postdose (AUC0-672)
Time frame: 33 weeks
AUC from time 0 extrapolated to infinity (AUC0-∞)
Time frame: 33 weeks
Percentage extrapolated AUC (%AUCext)
Time frame: 33 weeks
Apparent serum terminal elimination rate constant (λz)
Time frame: 33 weeks
Apparent total body clearance (CL/F)
Time frame: 33 weeks
Apparent volume of distribution during the terminal phase (Vz/F)
Time frame: 33 weeks
Apparent serum terminal elimination half-life (t½)
Time frame: 33 weeks
Percentage of Participants with Adverse Events
Time frame: 33 weeks
Tolerability- Percentage of participants who fail to complete the study
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Matching Placebo
Time frame: 33 weeks
Percentage of participants who fail to complete the study due to adverse events
Time frame: 33 Weeks