NCT02339207

First in Human Study of AL-335; Single Dose, Food Effect in Healthy Volunteers; Multiple Doses in Chronic Hepatitis C Genotype 1

A Randomized, Double-blind, Placebo-controlled, First-in-human, 3 Part Study of Orally Administered AL-335 to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Dosing and Food-effect in Healthy Volunteers, and Multiple Ascending Dosing in Subjects With Chronic Hepatitis C Genotype 1 Infection

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 112 (actual)
• Sponsor: Alios Biopharma Inc. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

This randomized, double-blind, placebo-controlled, 3-part study will assess the safety, tolerability, and pharmacokinetics of orally administered AL-335 in healthy volunteers (HV) and subjects with CHC infection.

Conditions

• Chronic Hepatitis C

Interventions

Type	Name	Description
DRUG	AL-335 matching placebo
DRUG	AL-335

Timeline

• Start date: 2014-12-31
• Primary completion: 2016-05-31
• Completion: 2016-05-31
• First posted: 2015-01-15
• Last updated: 2019-10-16

Locations

3 sites across 3 countries: France, Georgia, Moldova