Study of AT-777 in Healthy Subjects and AT-777 in Combination With AT-527 in HCV-Infected Subjects

A Phase I/IIa Study Assessing AT-777 in Healthy Subjects and AT-777 in Combination With AT-527 in HCV-Infected Subjects

This study has two parts. Part A will assess the safety, tolerability and pharmacokinetics (PK) of AT-777 in healthy subjects. Part B will assess the safety, antiviral activity/efficacy and PK of AT-777 in combination with AT-527 after 8 weeks of treatment in HCV-infected subjects.

Inclusion Criteria:

All:

• Body mass index (BMI) of 18-35 kg/m2
• Must agree to use protocol-specified methods of contraception
• Negative pregnancy test
• Willing to comply with the study requirements and to provide written informed consent

Additional for Part A:

-18-55 years of age

Additional for Part B:

• 18-65 years of age
• HCV genotype 1, 2 or 3
• Documented history compatible with chronic hepatitis C
• HCV RNA ≥ 10,000 IU/mL at Screening

Exclusion Criteria:

All:

• Pregnant or breastfeeding
• Abuse of alcohol or drugs
• Use of other investigational drugs within 30 days of dosing
• Other clinically significant medical conditions

Additional for Part B:

• Prior exposure to any HCV NS5A inhibitor
• Cirrhosis
• Co-infection with hepatitis B virus or HIV