A First in Human Study of AL-611 in Healthy Volunteers and Patients With Hepatitis C Virus Infection
Status:
Terminated
Trial end date:
2017-09-18
Target enrollment:
Participant gender:
Summary
This randomized, double-blind, placebo-controlled, 3-part study will assess the safety,
tolerability, pharmacokinetics (PK), and antiviral activity (Part 3 only) of orally
administered AL-611 in healthy volunteers (HV; Parts 1-2) and subjects with CHC (Part 3).
Part 1: HV will receive 1 of 5 single ascending doses (SAD) of AL-611 Part 2: Eight HV from
Cohort 3 in Part 1 are planned to receive a second single dose of AL-611 or placebo (as per
their randomized assignment in Part 1) in a fed state after a washout period Part 3: Subjects
with CHC infection will receive 1 of 3 planned multiple ascending doses (MAD)