NCT03253471

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

A Randomized, Double-blind, Placebo-controlled, First-in-human, 3 Part Study of Orally Administered AL-611 to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics (Part 3) of Single Ascending Doses in Healthy Volunteers (Parts 1-2), and Multiple Ascending Doses in Subjects With Chronic Hepatitis C Virus Infection (Part 3)

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Alios Biopharma Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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)

Conditions

• Hepatitis C

Interventions

Type	Name	Description
DRUG	AL-611	AL-611 tablets
DRUG	Placebo	Placebo to Match AL-611

Timeline

• Start date: 2017-07-07
• Primary completion: 2017-09-18
• Completion: 2017-09-18
• First posted: 2017-08-18
• Last updated: 2017-10-25

Locations

1 site across 1 country: Belgium