Study of AT-527 in Healthy and HCV-Infected Subjects
A Phase I Study Assessing Single and Multiple Doses of AT-527 in Healthy and HCV-Infected Subjects
Lead SponsorAtea Pharmaceuticals, Inc.
StatusCompleted No Results Posted
Indication/ConditionChronic Hepatitis C Hepatitis C Hepatitis C, Chronic
This study has multiple parts. It will assess the safety, tolerability and pharmacokinetics (PK) of AT-527 in healthy subjects and subjects infected with hepatitis C virus (HCV). In addition, the study will assess the antiviral activity of AT-527 in subjects infected with HCV.
Ascending doses of AT-527 administered orally.
Inclusion Criteria: All subjects (healthy and HCV-infected subjects): Must agree to use two methods of birth control from Screening through 90 days after administration of the last dose of study drug Must have a negative pregnancy test at Screening and prior to dosing Minimum body weight of 50 kg Willing to comply with the study requirements and to provide written informed consent Additional inclusion criteria for HCV-infected subjects: Must have not received prior treatment for HCV infection Documented clinical history compatible with chronic HCV infection Plasma HCV RNA ≥ 5.0 log10 IU/mL at Screening. Exclusion Criteria: All subjects (healthy and HCV-infected subjects): Pregnant or breastfeeding Infected with hepatitis B virus or HIV Abuse of alcohol or drugs Use of other investigational drugs within 28 days of dosing Other clinically significant medical conditions or laboratory abnormalities