This study is a randomized, double-blind, sponsor-open, placebo-controlled study. It will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of orally administered single and multiple doses of EDP-978 in healthy adult subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
98
ICON Early Phase
San Antonio, Texas, United States
RECRUITINGSafety measured by adverse events
Time frame: Up to 8 Days in SAD Cohorts
Safety measured by adverse events
Time frame: Up to 28 Days in MAD Cohorts
Cmax of EDP-978
Time frame: Up to 5 Days in SAD Cohorts
AUC of EDP-978
Time frame: Up to 5 Days in SAD Cohorts
Cmax of EDP-978
Time frame: Up to 18 Days in MAD Cohorts
AUC of EDP-978
Time frame: Up to 18 Days in MAD Cohorts
Cmax of EDP-938 (FE)
Food effects on plasma PK parameters of EDP-978
Time frame: Up to 12 Days in FE SAD Cohort
AUC of EDP-938 (FE)
Food effects on plasma PK parameters of EDP-978
Time frame: Up to 12 Days in FE SAD Cohort
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