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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
24
AL-611 tablets
Placebo to Match AL-611
SGS Life Sciences
Antwerp, Belgium
Incidence and severity of Treatment emergent Adverse events
Time frame: Up to 21 days
Physical examination findings
Time frame: Up to 21 days
Incidence and severity of vital sign abnormalities
Time frame: Up to 21 days
Incidence and severity of 12 lead electrocardiagram abnormalities
Time frame: Up to 21 days
Incidence and severity of clinical laboratory abnormalities
Time frame: Up to 21 days
Cmax of AL-611 and ALS-022358 (and other metabolites if applicable) following single dose administration
PK parameter of AL-611 and ALS-022358 (and other metabolites if applicable) following single dose administration
Time frame: Day 1 to Day 8
C0_h of AL-611 and ALS-022358 (and other metabolites if applicable) following repeat dose administration
PK parameter of AL-611 and ALS-022358 (and other metabolites if applicable) following repeat dose administration
Time frame: Day 1 to Day 21
Concentrations in urine of AL-611 and ALS 022358 (and other metabolites if applicable) after a single oral dose
Concentrations in urine of AL-611 and ALS 022358 (and other metabolites if applicable) after a single oral dose in HV in fasted conditions
Time frame: Day 1 to Day 8
HCV RNA viral load in subjects with CHC
HCV RNA viral load (over time, maximum decrease from baseline, and change from baseline over time) in subjects with CHC, defined by GT and host characteristic (eg, presence/absence of compensated cirrhosis)
Time frame: Screening to Day 21
Sequence analysis of HCV
Time frame: Day 1 to Day 21
tmax of AL-611 and ALS-022358 (and other metabolites if applicable) following single dose administration
PK parameter of AL-611 and ALS-022358 (and other metabolites if applicable) following single dose administration
Time frame: Day 1 to Day 8
C24h of AL-611 and ALS-022358 (and other metabolites if applicable) following single dose administration
PK parameter of AL-611 and ALS-022358 (and other metabolites if applicable) following single dose administration
Time frame: Day 1 to Day 8
Clast of AL-611 and ALS-022358 (and other metabolites if applicable) following single dose administration
PK parameter of AL-611 and ALS-022358 (and other metabolites if applicable) following single dose administration
Time frame: Day 1 to Day 8
tlast of AL-611 and ALS-022358 (and other metabolites if applicable) following single dose administration
PK parameter of AL-611 and ALS-022358 (and other metabolites if applicable) following single dose administration
Time frame: Day 1 to Day 8
t1/2 of AL-611 and ALS-022358 (and other metabolites if applicable) following single dose administration
PK parameter of AL-611 and ALS-022358 (and other metabolites if applicable) following single dose administration
Time frame: Day 1 to Day 8
CL/F of AL-611 and ALS-022358 (and other metabolites if applicable) following single dose administration
PK parameter of AL-611 and ALS-022358 (and other metabolites if applicable) following single dose administration
Time frame: Day 1 to Day 8
Vz/F of AL-611 following single dose administration
PK parameter of AL-611 following single dose administration
Time frame: Day 1 to Day 8
AUC0-inf of AL-611 and ALS-022358 (and other metabolites if applicable) following single dose administration
PK parameter of AL-611 and ALS-022358 (and other metabolites if applicable) following single dose administration
Time frame: Day 1 to Day 8
AUClast of AL-611 and ALS-022358 (and other metabolites if applicable) following single dose administration
PK parameter of AL-611 and ALS-022358 (and other metabolites if applicable) following single dose administration
Time frame: Day 1 to Day 8
Cmax of AL-611 and ALS-022358 (and other metabolites if applicable) following repeat dose administration
PK parameters of AL-611 and ALS-022358 (and other metabolites if applicable) following repeat dose administration
Time frame: Day 1 to Day 21
tmax of AL-611 and ALS-022358 (and other metabolites if applicable) following repeat dose administration
PK parameter of AL-611 and ALS-022358 (and other metabolites if applicable) following repeat dose administration
Time frame: Day 1 to Day 21
Cmin of AL-611 and ALS-022358 (and other metabolites if applicable) following repeat dose administration
PK parameters of AL-611 and ALS-022358 (and other metabolites if applicable) following repeat dose administration
Time frame: Day 1 to Day 21
t1/2 of AL-611 and ALS-022358 (and other metabolites if applicable) following repeat dose administration
PK parameters of AL-611 and ALS-022358 (and other metabolites if applicable) following repeat dose administration
Time frame: Day 1 to Day 21
AUClast of AL-611 and ALS-022358 (and other metabolites if applicable) following repeat dose administration
PK parameters of AL-611 and ALS-022358 (and other metabolites if applicable) following repeat dose administration
Time frame: Day 1 to Day 21
AUC0_tau of AL-611 and ALS-022358 (and other metabolites if applicable) following repeat dose administration
PK parameter of AL-611 and ALS-022358 (and other metabolites if applicable) following repeat dose administration
Time frame: Day 1 to Day 21
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.