drugset / Trial / NCT03253471

A First in Human Study of AL-611 in Healthy Volunteers and Patients With Hepatitis C Virus Infection

NCT03253471 ↗

Phase 1 Terminated 24 enrolled Alios Biopharma Inc.
RandomizedParallel-groupQuadruple-blindTreatment

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)

Timeline

Start
2017-07-07
Primary completion
2017-09-18
Completion
2017-09-18

Outcome

Outcome not reported

Stopped (Business): “Strategic decision to discontinue further development of investigational compounds for the treatment of hepatitis C.”

Drugs

EvaluationDrugModalityDoseRoute
Subject AL-611 Unknown — Oral