Replies to post #1258 on Enanta Pharmaceuticals Inc (ENTA)

[NY1972]

EDP-494 P1 started

A Randomized, Double-Blind, Pbo-Controlled, Study of EDP-494 to Evaluate the Safety and PK of SAD/FE in Healthy Subjects and MAD in Healthy and in Subjects With CHC Infection (POC)

The first phase explores single ascending doses of EDP-494 (active drug or placebo) in healthy subjects. A 'fasted' vs 'fed' two-part cohort will also assess food effect.

The second phase involves multiple ascending doses (active drug or placebo) for 14 days in healthy subjects.

The third, proof of concept, phase will assess two different doses for 14 days each in Hepatitis C patients.

Each cohort within each phase will consist of 8 subjects randomized to either EDP-494 or placebo in a 3 to 1 ratio, with the exception of the food effect cohort, which will consist of 10 subjects randomised in a 4 to 1 ratio.

https://www.clinicaltrials.gov/ct2/show/NCT02652377?term=EDP-494&rank=1