First in Human Study of AL-704; Single Dose, Food Effect in Healthy Volunteers; Multiple Doses in Chronic Hepatitis C

Inclusion Criteria

• •Subject must be a man or woman 18 to 60 years of age, inclusive for healthy subjects, or 18 to 65 years of age, inclusive for subjects with CHC infection.
• •Each subject must sign an ICF indicating that he or she understands the purpose of and procedures required for the study and are willing to participate in the study before starting any screening activities.
• •Subject must be willing and able to adhere to the prohibitions and restrictions
• •Subject included in Part 1 and 2 of the study, must be non-smokers for at least 3 months prior to screening.
• •Subject included in Part 1 and 2 of the study, must be healthy on the basis of a medical evaluation that reveals the absence of any clinically relevant abnormality and includes a physical examination, medical history, vital signs, and the results of biochemistry, and hematology tests and a urinalysis performed at screening and admission. If there are abnormalities, the subject may be included only if the Investigator judges the abnormalities or deviations from normal to be not clinically significant. This determination must be recorded in the subject's source documents and initialed by the Investigator.
• •Subject with CHC infection included in Part 3 of the study, must be otherwise healthy on the basis of a medical evaluation that reveals the absence of any clinically relevant abnormality other than those related to CHC infection, and includes a physical examination, medical history, vital signs, and the results of blood biochemistry, blood coagulation and hematology tests and a urinalysis performed at screening and admission. If there are abnormalities, the subject may be included only if the Investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the subject's source documents and initialed by the Investigator and the Sponsor.
• •Subject included in Part 1 and 2 of the study, must have a body mass index (BMI) of 18.0 to 32.0 kg/m2, extremes included. Subjects with CHC infection included in Part 3 of the study must have a BMI of 18.0 to 35.0 kg/m2, extremes included, with a minimum weight of 50 kg in both populations. No more than 25% of patients in any cohort may be enrolled with a BMI ≥30 kg/m2.
• •Female subject must be of non-childbearing potential.
• •Female subject, except if postmenopausal, should have a negative serum pregnancy test at screening and a negative urine pregnancy test at admission.
• •Subject must agree to comply with contraceptive measures .
• •Subject must have a normal 12-lead ECG (based on the mean value of the triplicate parameters at admission)
• •Documentation of HCV infection for longer than 6 months and determination of genotype 1 or 3 HCV infection at screening. In case of discrepancy between previously documented geno- or subtype and the geno- or subtype determined at screening, the eligibility results will be used to determine eligibility.
• •HCV RNA viral load ≥105 IU/mL using a sensitive quantitative assay