This randomized, double-blind, placebo-controlled, 3-part study will assess the safety, tolerability, and pharmacokinetics of orally administered ALS-002200 in healthy volunteers (HV) and subjects with chronic hepatitis C (CHC) genotype 1 infection. Part 1 will assess single ascending dosing pharmacokinetics and safety in HV. Part 2 will assess food effects on pharmacokinetics in HV. Part 3 will assess multiple ascending dosing pharmacokinetics and safety in subjects with CHC genotype 1 infection.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
71
ALS-002200
Placebo
Biotrial
Rennes, Brittany Region, France
Biotrial
Paris, France
Arensia
Chisinau, Moldova
Arensia
Bucharest, Romania
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
data points measured include patient reported adverse events, physical exams, vital signs, 12-lead ECGs and clinical lab results
Time frame: up to Day 31
Cmax
Time frame: pre-dose and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 240 hours post dose
AUC
Time frame: pre-dose and 0.25, 0.5, 1, 2, 3,4, 6, 8, 12, 24, 36, 48, 72, 96, 120 and 240 hours post dose
HCV ribonucleic acid (RNA) viral load reduction
Time frame: Baseline to Day 31
Amino Acid Changes in HCV polymerase NS5b
Comparison of baseline with on-treatment or post-treatment Hepatitis C virus (HCV) NS5B RNA sequence
Time frame: Baseline up to Month 6
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