This study is a randomized, double-blind, placebo-controlled study. It will assess the safety, tolerability, and pharmacokinetics of orally administered single and multiple doses of EDP-235 in healthy adult subjects.
The first phase assesses single ascending doses of EDP-235 or placebo in healthy subjects. A "fasted" and "fed" two-part cohort will also assess food effect. The second phase assesses multiple ascending doses of EDP-235 or placebo for 7-days in healthy subjects. Each cohort within each phase will enroll a total of 8 subjects who will be randomized to receive EDP-235 or placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
72
Pharmaceutical Research Associates, Inc.,
Lenexa, Kansas, United States
Safety measured by adverse events
Time frame: Up to 8 Days in HV SAD Cohorts
Safety measured by adverse events
Time frame: Up to 14 Days in HV MAD Cohorts
Cmax of EDP-235
Time frame: Up to 5 Days in HV SAD Cohorts
AUC of EDP-235
Time frame: Up to 5 Days in HV SAD Cohorts
Cmax of EDP-235
Time frame: Up to 11 Days in HV MAD Cohorts
AUC of EDP-235
Time frame: Up to 11 Days in HV MAD Cohorts
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