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

NCT03253471 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2017-10-25

No results posted yet for this study

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

DRUG

AL-611

AL-611 tablets

DRUG

Placebo

Placebo to Match AL-611

Sponsors & Collaborators

  • Alios Biopharma Inc.

    lead INDUSTRY

Principal Investigators

  • Mina Pastagia · Alios Biopharma

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03253471 on ClinicalTrials.gov